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Aims: Recently a limited sampling strategy (LSS) for determination of metformin' pharmacokinetics was developed. The LSS utilizes the plasma concentration of metformin 3 and 10 hours after oral intake of a single dose to estimate the area under the concentration–time curve up to 24 hours (AUC 0–24h). The main purpose of this study was to support the feasibility of this strategy in a large prospective trial. Methods: Volunteers orally ingested two 500-mg tablets of metformin hydrochloride. A blood sample was drawn three and ten hours after the ingestion. Urine was collected for 0–10 and 10–24 hours and urine volumes recorded. The AUC 0–24h was calculated using the equation AUC 0–24h = 4.779 * C 3 + 13.174 * C 10. Additionally, all participants were genotyped for the single-nucleotide polymorphism A270S in OCT2, g.-66 T > C in MATE1, R61C, G465R, G401S and the deletion M420del in OCT1. Results: In total, 212 healthy volunteers participated. The median (25th - 75th interquartile range) AUC 0 − 24h, CL renal, C 3 and C 10, were 10 600 (8470–12 500) ng* hr* mL −1, 29 (24–34) L* hour −1, 1460 (1180–1770) and 260 (200–330) ng* mL −1, respectively, which is in agreement with our previous results. GFR i was correlated with metformin AUC and CL renal (P 0 − 24h. We were unable to reproduce our previous finding of a gene–gene interaction (OCT2 and MATE1) effect on CL renal in this cohort. Conclusion: This study further supports the use of the 2-point LSS algorithm in large pharmacokinetic trials.

Recently, nonexposure simple suturing endoscopic full-thickness resection (NESS-EFTR) method was developed to avoid tumor exposure to the peritoneal cavity. The aim of this study is to compare the short-term outcomes of the NESS-EFTR method with those of laparoscopic and endoscopic cooperative surgery (LECS) for gastric subepithelial tumors (SETs). A prospective single-center trial of LECS for gastric SETs was performed from March 2012 to October 2013 with a separate prospective trial of NESS-EFTR performed from August 2015 to June 2017, enrolling 15 patients each. Among the 30 enrolled patients, 14 who underwent LECS and 11 who underwent NESS-EFTR were finally included in the analysis. The rate of complete resection and successful closure was 100% in both groups. The operating time was longer for NESS-EFTR group than for LECS (110 vs. 189 min, p &lt, 0.0001). There were no postoperative complications except one case of transient fever in the NESS-EFTR group. One patient in the LECS group had peritoneal seeding of gastrointestinal stromal tumor at 17 months postoperatively, and there was no other recurrence. Although NESS-EFTR had long operating and procedure times, it was feasible for patients with gastric SETs requiring a nonexposure technique.

BACKGROUND: Transbronchial cryobiopsies has become increasingly important in the diagnostic workup for interstitial lung diseases. The rate of complications and mortality are low compared to surgical lung biopsies, but the diagnostic yield is not as high. The reason for the lower diagnostic yield could in some cases be explained by biopsies taken too centrally or in less affected areas. In this pilot study we examined the feasibility of using the electromagnetic navigation system, superDimension (SD), when performing cryobiopsies to increase the diagnostic yield.METHODS: Electromagnetic navigation bronchoscopy and cryobiopsies were performed using SD. An electromagnetic board placed on the back of the patient and a position sensor at the tip of the navigational probe created a real-time 3D reconstruction of previously acquired computer tomography images. The procedure was performed with the patients in general anesthesia using a rigid bronchoscope when performed in Florence and with a flexible bronchoscope through an orotracheal tube when performed in Aarhus.RESULTS: In total, 18 patients were included. Five patients were excluded, partly due to technical difficulties. Disposable 1.7 mm cryoprobes were used in Aarhus, and reusable 1.9 mm probes in Florence. Pneumothorax was detected in three (23%), mild hemorrhage was seen in one (8%) and moderate hemorrhage in six (46%). The biopsies contributed to the diagnosis in 11 of the patients (85%).CONCLUSION: Using superDimension electromagnetic navigation system when performing cryobiopsies is feasible. A larger prospective trial is necessary to homogenize the technique between centres and to evaluate diagnostic advantage and complications.

Introduction: Artificial intelligence (AI) can automate the detection and triage of ICH. ENRICH is a RCT evaluating the efficacy of MIS for ICH. AI ENRICH is a prospective trial operating within and in parallel to the ENRICH trial that utilizes an AI application, Viz RECRUIT and ICH VOLUME to identify and segment ICH to quickly identify potentially eligible subjects. Methods: Non-contrast CT scans performed at 5 participating US hospitals were evaluated specifically for a parenchymal hemorrhage by Viz ICH VOLUME. Participating health care professionals downloaded a phone application that allowed one to be notified for any hemorrhage ≥ 5 mL. Time metrics included the onset of CT scan, phone alert, and user recognition of that alert. Results: Over a combined period of 220 days, 8714 CT scans were evaluated by the Viz ICH VOLUME application. Of these, 257 CT scans were determined to contain an ICH yielding a total of 45 patients that met ENRICH criteria for trial inclusion (30-80 mL). The median time from CT scan to cell phone notification was 2:52 minutes (IQR=0.002) . The median time from cell phone notification to the user viewing the CT scan was 3:00 minutes (IQR=55.5 minutes), which was altered by a few significant delays in recognizing the alert (e.g. coordination of alerts and call schedules). After segregating the 4 weeks after ENRICH restarted on 7/14/20 into 2 week blocks, recognition of an alert within 5 minutes increased from 9% to 61.5% at the first site and 36% to 61.5% at second site - demonstrating the ability of alerts to improve site engagement and active screening for new subjects. Conclusions: In conclusion, Viz ICH VOLUME can screen large numbers of CT scans and send alerts within minutes to medical professionals. Studies relying on radiographic selection criteria may benefit from automated screening, although participating health care providers need to make use of the technology in order to maximize benefit.

Purpose Prostate specific membrane antigen (PSMA) PET/CT is increasingly used in men with biochemical recurrence post-prostatectomy to detect local recurrence and metastatic disease at low PSA levels. The aim of this study was to assess patterns of disease detection, predictive factors and safety using 18F-DCFPyL PET/CT versus diagnostic CT in men being considered for salvage radiotherapy with biochemical recurrence post-prostatectomy.Methods We conducted a prospective trial recruiting 100 patients with biochemical failure post-prostatectomy (PSA 0.2-2.0ng/mL) in men referred for salvage radiotherapy from August 2018 to July 2020. All patients underwent a PSMA PET/CT using the 18F-DCFPyL tracer and a diagnostic CT. The detection rates of 18F-DCFPyL PET/CT vs diagnostic CT were compared and patterns of disease are reported. Clinical patient and tumour characteristics were analysed for predictive utility. Thirty-day post-scan safety is reported.Results Of 100 patients recruited, 98 were suitable for analysis with a median PSA of 0.32ng/mL. 18F-DCFPyL PET/CT was positive or equivocal in 52% compared to 19.6% for diagnostic CT. Local recurrence was detected on 18F-DCFPyL PET/CT in 29.2%, nodal disease was seen in 29.6% and bony metastases in 7.1%. Both ISUP grade group (p = 0.003) and pre-scan PSA (p = 0.061) were significant predictors of 18F-DCFPyL PET/CT positivity, and logistic regression generated probabilities combining the two showed improved prediction rates. No significant safety events were reported post 18F-DCFPyL administration.Conclusions 18F-DCFPyL PET/CT increases detection of disease in men with biochemical recurrence post-prostatectomy compared to diagnostic CT. Men being considered for salvage radiotherapy with a PSA > 0.2ng/mL should be considered for 18F-DCFPyL PET/CT scan.Clinical Trial Registration Australian New Zealand Clinical Trials Registry Number: ACTRN12618001530213. Registration date 13.9.2018 http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375932&isReview=true

Concern for discordance between clinical staging and final pathology drives current management of patients deemed appropriate candidates for radical cystectomy. Therefore, we set out to prospectively investigate reliability and shortcomings of cystoscopic evaluation in radical cystectomy candidates.Patients undergoing radical cystectomy for urothelial carcinoma were enrolled in a prospective single-arm study to evaluate reliability of Systematic Endoscopic Evaluation in predicting pT0 urothelial carcinoma (NCT02968732). Systematic Endoscopic Evaluation consisted of cystoscopy and tissue sampling at the time of radical cystectomy. Systematic Endoscopic Evaluation results were compared to radical cystectomy pathology. The primary end point was the negative predictive value of Systematic Endoscopic Evaluation findings in predicting radical cystectomy pathology.A total of 61 patients underwent Systematic Endoscopic Evaluation and radical cystectomy. Indications included muscle invasive bladder cancer in 42 (68.9%) and high risk nonmuscle invasive bladder cancer in 19 (31.1%). In all, 38 (62.3%, 90.5% of patients with muscle invasive bladder cancer) received neoadjuvant chemotherapy. On Systematic Endoscopic Evaluation, 31 (50.8%) patients demonstrated no visual nor biopsy-based evidence of disease (seeT0), yet 16/31 (51.6%) harbored residual disease (pT0), including 8 (8/31, 25.8%) with residual ≥pT2 disease upon radical cystectomy. The negative predictive value of Systematic Endoscopic Evaluation predicting a pT0 bladder was 48.4% (CI 30.2-66.9), which was below our prespecified hypothesis. Therefore, the trial was stopped for futility.Approximately 1 of 4 patients with seeT0 at the time of radical cystectomy harbored residual muscle invasive bladder cancer. These prospective data definitively confirm major limitations of endoscopic assessment for pT0 bladder cancer. Future work should focus on novel imaging and biomarker strategies to optimize evaluations before radical cystectomy for improved decision making regarding bladder preservation.

ContextFollowing total thyroidectomy and radioactive iodine (RAI) ablation, serum thyroglobulin levels should be undetectable to assure that patients are excellent responders and at very low risk of recurrence.ObjectiveTo assess the utility of stimulated (sTg) and non-stimulated (nsTg) thyroglobulin levels in prediction of patients outcomes with differentiated thyroid cancer (DTC) following total thyroidectomy and RAI ablation.MethodA prospective observational study conducted at a University Hospital in Saudi Arabia. Patients diagnosed with differentiated thyroid cancer and were post total thyroidectomy and RAI ablation. Thyroglobulin levels (nsTg and sTg) were estimated 3–6 months post-RAI. Patients with nsTg ResultsOf 196 patients, nsTg levels were 1 occurred in 26 (35%) of patients with nsTg 0.1–2.0 ng/ml, 11 (15%) had structural incomplete response. None of the patients with sTg levels ConclusionSuppressed thyroglobulin (nsTg < 0.1 ng/ml) indicates a very low risk of recurrence that does not require stimulation. Stimulated thyroglobulin is beneficial with nsTg 0.1–2 ng/ml for re-classifying patients and estimating their risk for incomplete responses over a 7 years follow-up period.

Objective: Arteriovenous fistulas created for hemodialysis often fail to become usable and are frequently abandoned. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in increasing radiocephalic fistula use for hemodialysis and secondary patency. Methods: PATENCY-2 was a randomized, double-blind, placebo-controlled trial in patients on or approaching the need for hemodialysis undergoing radiocephalic arteriovenous fistula creation. Of 696 screened, 613 were randomized, and 603 were treated (vonapanitase n = 405, placebo n = 208). The study drug solution was applied topically to the artery and vein for 10 min immediately after fistula creation. The primary endpoints were fistula use for hemodialysis and secondary patency (fistula survival without abandonment). Other efficacy endpoints included unassisted fistula use for hemodialysis, primary unassisted patency, fistula maturation and unassisted maturation by ultrasound criteria, and fistula procedure rates. Results: The proportions of patients with fistula use for hemodialysis was similar between groups, 70% vonapanitase and 65% placebo, ( p = 0.33). The Kaplan–Meier estimates of 12-month secondary patency were 78% (95% confidence interval [CI], 73–82) for vonapanitase and 76% (95% CI, 70–82) for placebo ( p = 0.93). The proportions with unassisted fistula use for hemodialysis were 46% vonapanitase and 37% placebo ( p = 0.054). The Kaplan–Meier estimates of 12-month primary unassisted patency were 50% (95% CI, 44–55) for vonapanitase and 43% (95% CI, 35–50) for placebo ( p = 0.18). There were no differences in the proportion of patients with fistula maturation or in fistula procedure rates. Adverse events were similar between groups. Vonapanitase was not immunogenic. Conclusions: Vonapanitase treatment did not achieve clinical or statistical significance to meaningfully improve radiocephalic fistula surgical outcomes. Outcome in the placebo group were better than in historical controls. Vonapanitase was well-tolerated and safe. TRIAL REGISTRATION: clinicaltrials.gov: NCT02414841 ( https://clinicaltrials.gov/ct2/show/NCT02414841 )

Background Lack of sustainable access to clean drinking water continues to be an issue of paramount global importance, leading to millions of preventable deaths annually. Best practices for providing sustainable access to clean drinking water, however, remain unclear. Widespread installation of low-cost, in-home, point of use water filtration systems is a promising strategy. Methods We conducted a prospective, randomized, controlled trial whereby 16 villages were selected and randomly assigned to one of four treatment arms based on the installation location of Sawyer® PointONE™ filters (filter in both home and school; filter in home only; filter in school only; control group). Water samples and self-reported information on diarrhea were collected at multiple times throughout the study. Results Self-reported household prevalence of diarrhea decreased from 25.6 to 9.76% from installation to follow-up (at least 7 days, and up to 200 days post-filter installation). These declines were also observed in diarrhea with economic or educational consequences (diarrhea which led to medical treatment and/or missing school or work) with baseline prevalence of 9.64% declining to 1.57%. Decreases in diarrhea prevalence were observed across age groups. There was no evidence of a loss of efficacy of filters up to 200 days post-filter installation. Installation of filters in schools was not associated with decreases in diarrhea prevalence in school-aged children or family members. Unfiltered water samples both at schools and homes contained potential waterborne bacterial pathogens, dissolved heavy metals and metals associated with particulates. All dissolved metals were detected at levels below World Health Organization action guidelines. Conclusions This controlled trial provides strong evidence of the effectiveness of point-of-use, hollow fiber membrane filters at reducing diarrhea from bacterial sources up to 200 days post-installation when installed in homes. No statistically significant reduction in diarrhea was found when filters were installed in schools. Further research is needed in order to explore filter efficacy and utilization after 200 days post-installation. Trial registration ClinicalTrials.gov, NCT03972618. Registered 3 June 2019—retrospectively registered.

To elucidate early and long-term continence and patient comfort depending on type and duration of catheterization after robot-assisted radical prostatectomy. 198 patients were randomized prospectively into three groups (May 2016–July 2017): A transurethral catheter with micturition on postoperative day (POD) 5 was placed in the control group (TD5); a suprapubic tube (SPT) with micturition on POD 5 was placed in the group SD5 or with micturition on POD 2 in group SD2, respectively. Questionnaires were used for catheter-related satisfaction. Functional outcome analysis included residual volume analysis, uroflowmetry, IPSS, 12-h pad test, and daily pad use. Follow-up was conducted up to 12 months. Postoperative comfort and catheter-related complications were similar in the three groups. However, on the day of catheter removal, continence was significantly better in the 12-h pad test for the SD2 group with 14 ml vs. 30 ml (TD5) and 24 ml (SD5), p = 0.007. Median residual urine volume between the groups was comparable with 17 ml in TD5, 7 ml in SD5, and 11 ml in SD2, (p = 0.07). Postoperative IPSS did not differ significantly in the follow-up period. After 4 weeks, 63% of the patients in SD2 were continent (no pad/day) compared to 33% in TD5 and 41% in SD5, p = 0.004. After 12 months, 76% were continent in TD5, 87% in SD5, and 94% in SD2, p = 0.023. Early micturition after SPT placement in robotic radical prostatectomy seems to be beneficial without an increased risk of complications.

To compare FDG-PET/unenhanced MRI and FDG-PET/diagnostic CT in detecting infiltration in patients with newly diagnosed Hodgkin lymphoma (HL). The endpoint was equivalence between PET/MRI and PET/CT in correctly defining the revised Ann Arbor staging system. Seventy consecutive patients with classical-HL were prospectively investigated for nodal and extra-nodal involvement during pretreatment staging with same-day PET/CT and PET/MRI. Findings indicative of malignancy with the imaging procedures were regarded as lymphoma infiltration; in case of discrepancy, positive-biopsy and/or response to treatment were evidenced as lymphoma. Sixty of the 70 (86%) patients were evaluable having completed the staging program. Disease staging based on either PET/MRI or PET/CT was correct for 54 of the 60 patients (90% vs. 90%), with difference between proportions of 0.0 (95% CI, −9 to 9%; P=0.034 for the equivalence test). As compared with reference standard, invasion of lymph nodes was identified with PET/MRI in 100% and with PET/CT in 100%, of the spleen with PET/MRI in 66% and PET/CT in 55%, of the lung with PET/MRI in 60% and PET/CT in 100%, of the liver with PET/MRI in 67% and PET/CT in 100%, and of the bone with PET/MRI in 100% and PET/CT in 50%. The only statistically significant difference between PET/MRI and PET/CT was observed in bony infiltration detection rates. For PET/CT, iodinate contrast medium infusions’ average was 86 mL, and exposure to ionizing radiation was estimated to be 4-fold higher than PET/MRI. PET/MRI is a promising safe new alternative in the care of patients with HL. Supplementary Information The online version contains supplementary material available at 10.1007/s00277-021-04537-5.

OBJECTIVES Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) uses a thin needle, rendering unclear whether the collected sample contains pathological evidence. We examined the usefulness of our target sample check illuminator (TSCI) through a multicenter prospective trial. METHODS We included 52 consecutive patients. After assessing EUS-FNB samples by conventional (visual observation) and TSCI methods, we evaluated consistency with the histopathological diagnosis. We compared the target sample confirmation rate between conventional and TSCI methods and evaluated the diagnostic ability separately. RESULTS Comparison between the conventional and TSCI methods revealed the following: (i) for all cases: sensitivity, 51.0% (25/49) vs. 95.9% (47/49) (P = 0.001); specificity, 100% (3/3) vs. 66.7% (2/3); positive predictive value (PPV), 100% (25/25) vs. 97.9% (47/48); and negative predictive value (NPV), 11.1% (3/27) vs. 50.0% (2/4) (P = 0.002); (ii) for pancreatic masses: sensitivity, 28.0% (7/25) vs. 96.0% (24/25) (P

Objective The study aimed to evaluate the impact of 17-hydroxyprogesterone caproate (17-OHPC) on recurrent preterm birth (PTB) in women with a prior PTB and a current dichorionic/diamniotic twin gestation. Study design We combined individual patient-level data from two prospective randomized placebo-controlled trials of prophylactic 17-OHPC in twin gestation and compared the rates of recurrent spontaneous PTB in those women with a prior singleton PTB randomized to placebo or 17-OHPC (250 mg weekly). Results Only 7.4% of women with dichorionic/diamniotic twin gestation experienced a prior PTB. Among these 66 women, spontaneous delivery prior to 34 weeks occurred significantly less often (p = 0.03) in those randomized to 17-OHPC (20.6%) than in those randomized to placebo (46.9%). However, mean gestational length was not significantly different, and there was no statistically significant difference in composite neonatal outcome. Conclusion 17-OHPC may be beneficial to women with a prior PTB and a current dichorionic/diamniotic twin gestation. These findings along with those reported by the Maternal Fetal Medicine Units Network in singletons suggest a common mechanism of action and a specific target population, those with a prior PTB, that may benefit from 17-OHPC treatment. A large prospective trial is needed to validate these findings. Key points · 17-OHPC reduces recurrent PTB in women with dichorionic/diamniotic twins.. · PTB risk and response to 17-OHPC may differ according to the type of twinning.. · 17-OHPC may affect a common pathway in twins and singletons with a prior PTB..

Background Treatment-free survival (TFS) in chronic myeloid leukemia (CML) is a new goal. This prospective study aims to evaluate imatinib discontinuation's feasibility and safety in patients with deep molecular response MR4 (BCR-ABL1 Methods Study was approved by the ethical committee and registered at Clinicaltrials.gov (NCT03239886). Incluision criteria were: age ≥ 18y, chronic phase, first-line imatinib for 36 months, MR4 for 12 months, no previous transplant or resistance. Imatinib was resumed when two samples confirmed the loss of MMR. The primary endpoint was molecular recurrence-free survival (MRFS) at 24 months. Lymphocyte subpopulations were counted in peripheral blood before discontinuation. Results 31 patients were included from Dec/2016 until Oct/2017. Median age was 54years, 58 % male, 58 % low Sokal, 65 % b3a2 transcripts, and 61 % were in MR4.5. Imatinib therapy's median time was 9.7y (3−14.9 y), median time of MR4 was 6.9y (1.6−10.3y). MRFS at 24 months was 55 % (95 % CI 39–75). Thirteen patients relapsed, 46 % after six months of discontinuation, and all patients recovered MMR. Median time to recover MMR was one month. MR4.5 was the only factor associated with MRFS. NK cells proportion at baseline was lower in patients with only MR4 who relapsed after discontinuation. Conclusion With a median duration of sustained MR4 above five years, as recommended by most TKI discontinuation guidelines, the TFS was similar to previous studies. Only MR4.5 was associated with lower risk of relapse. Further studies are needed to evaluate whether patients with only MR4 and low NK cell levels are suitable for discontinuation.

Background Despite the availability of effective treatment, the control of hypertension remains insufficient. Telemonitoring in the management of hypertension would be an effective way to improve blood pressure control. Objective The aim of our study will be to evaluate the effects of telemonitoring with antihypertensive treatment titration on blood pressure control in Tunisian patients with hypertension. Methods Our trial will be a prospective, rater-blinded randomized controlled trial carried out with primary care physicians in the Sahel region of Tunisia. Patients will be eligible for enrollment if they are aged over 35 years, are newly diagnosed with hypertension, or are known to be poorly controlled on antihypertensive therapy. Participants will be randomly assigned in a 1:1 ratio to the telemonitoring arm or usual care arm. The telemonitoring arm will involve a weekly telephone call for the collection of the home blood pressure measurements, therapeutic education, and treatment compliance assessment as well as a monthly call for treatment titration and a side effect check. Randomization will be done via the use of an interactive web responsive system, and patients will be stratified by investigation center. Neither participants nor investigators will be masked to the group assignments. The primary outcome will be the change in mean 24-hour systolic blood pressure from baseline to the 6-month follow-up in the 2 groups. All randomized patients who attend the follow-up visit at 6 months and have no missing data for the primary outcome will be included in the analysis. Results Recruitment to the trial started in July 2020. The study was initiated with 17 primary care physicians. We expect the inclusion period to last for approximately 6 months. We expect to complete data collection by the end of 2021 and plan to disseminate the results subsequently. Conclusions The HOROSCOPE (Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Randomized Controlled Prospective Trial) study will provide important new evidence that could shed some light on the feasibility and impact of telemonitoring and self-monitoring in a Tunisian population of patients with hypertension who consult primary care physicians. Trial Registration ClinicalTrials.gov NCT04607239; https://clinicaltrials.gov/ct2/show/NCT04607239 International Registered Report Identifier (IRRID) DERR1-10.2196/26184

Objectives This prospective study evaluates the effectiveness and safety of venous sinus stenting for patients with isolated pulsatile tinnitus and lateral sinus stenosis. Methods Patients with isolated pulsatile tinnitus and lateral sinus stenosis with a minimum trans stenotic gradient of 4 mm Hg were treated with stenting. Pulsatile tinnitus before and after treatment was assessed with the Tinnitus Handicap Inventory (THI). Periprocedural adverse events, neurological complications, clinical and radiographic follow-up were also recorded. Results A total of 42 patients (41 females and 1 male) were included in the study (median age of 37.5 years). Thirty patients had post-stenotic fusiform and 12 had post-stenotic saccular venous sinus aneurysm. In addition to stenting, coils were used to treat the patients with saccular venous aneurysms. The median follow-up was 5 months (range 1 to 34 months). Most patients had complete (39/42) or near-complete (2/42) resolution of their pulsatile tinnitus post-procedure. There were no serious adverse events. Conclusion Stenting of the lateral venous sinus is a safe and effective treatment for patients with isolated pulsatile tinnitus due to venous sinus stenosis.

Introduction: Aging is characterized by the progressive loss of physiological capacity. Changes in gene expression can alter activity in defined age-related molecular pathways leading to cellular aging and increased aging disease susceptibility. The aim of the current study was to evaluate whether hyperbaric oxygen therapy (HBOT) affects gene expression in normal, non-pathological, aging adults. Methods: Thirty-five healthy independently living adults, aged 64 and older, were enrolled to receive 60 daily HBOT exposures. Whole blood samples were collected at baseline, at the 30th and 60th HBOT session, and 1–2 weeks following the last session. Differential gene expression analysis was performed. Results: Following 60 sessions of HBOT, 1342 genes and 570 genes were differently up- and downregulated (1912 total), respectively (p < 0.01 FDR), compared to baseline. Out of which, five genes were downregulated with a >1.5-fold change: ABCA13 (FC = −2.28), DNAJ6 (FC = −2.16), HBG2 (FC = −1.56), PDXDC1 (FC = −1.53), RANBP17 (FC = −1.75). Two weeks post-HBOT, ABCA13 expression was significantly downregulated with a >1.5fold change (FC = −1.54, p = 0.008). In conclusion, for the first time in humans, the study provides direct evidence of HBOT is associated with transcriptome changes in whole-blood samples. Our results demonstrate significant changes in gene expression of normal aging population.

BACKGROUND In BIOMARK trial, patients with newly diagnosed glioblastoma were treated with standard chemoradiotherapy combined with first-line bevacizumab; a subset of patients continued bevacizumab beyond progression (BBP). Neurocognitive function (NCF), symptom burden, and health-related quality of life (HRQoL) were examined as secondary endpoints. PATIENTS AND METHODS In the primary protocol, newly diagnosed glioblastoma patients aged 20-75 received standard 6-week radiotherapy combined with temozolomide and bevacizumab followed by 4-week cycles of temozolomide plus bevacizumab, and then 2-3-week cycles of bevacizumab monotherapy. Upon recurrence, patients were subjected to the secondary protocol with 2-3-week cycles of bevacizumab monotherapy with or without other chemotherapeutic agents. NCF tests (Hopkins verbal learning test-revised, trail making test, and controlled oral word association), EORTC QLQ-C30/BN20, and MDASI-BT were completed by the patients. Time to deterioration (TTD) was defined as the time from randomization until a pre-specified change from baseline without further improvement or death. The Kaplan-Meier method and the log-rank test were used to assess TTD for each subscale of the above tests. RESULTS Overall, 94 patients were enrolled in the study. Analyses were based on the full analysis set cohort (N=90), excluding non-glioblastoma diagnosis by central review. The median overall survival (OS) and progression-free survival (PFS) were 25.0 and 14.9 months, respectively. Baseline HRQoL and symptom burden subscales (emotional functioning, symptom severity score, affective factor, and focal factor) were significantly associated with PFS. The median TTD was 8.7, 7.5, 8.1 months for global health status/QoL, symptom severity score, interference score, respectively. Among patients who experienced recurrence, disease progression was apparently preceded by deterioration in terms of symptom burden. CONCLUSIONS Detailed analysis of HRQoL and symptom burden may aid care of glioblastoma patients throughout the disease trajectory.

INTRODUCTION Achieving durable local control (LC) for aggressive or recurrent meningiomas remains problematic. Resection (R) alone is insufficient and even with the addition of radiation therapy (RT), outcomes are suboptimal in many series. OBJECTIVE Hypothesizing R plus Surgically Targeted Radiation Therapy (STaRT) may improve LC, we evaluated a permanently implanted brachytherapy device consisting of Cs-131 seeds positioned within modular resorbable collagen carrier/spacer tiles (GammaTile, GT Medical Technologies, Tempe AZ). METHODS From 2/2013-2/2018 recurrent and newly diagnosed aggressive meningiomas were treated on a prospective single-arm study (NCT#03088579). At completion of maximum safe resection the tumor bed was lined with collagen tiles imbedded with Cs-131, delivering 60–80 Gy at 5 mm depth. No additional local therapy was given absent progression. RESULTS 35 meningiomas in 28 patients were treated; 29 recurrent (22 prior R+RT, 6 R only, and 1 RT only) and 6 without prior therapy. WHO grade was I in 2 patients, II in 28, and III in 5. Median age was 66 years (range 37–82), KPS 80 (70–100), female: male ratio 15:13. Mean time for implantation was 5 minutes. At a median radiographic follow-up of 25.5 months (range 0.1–71) LC was 80% (28/35) and median time to progression had not been reached (95% CI > 35.6 months). LC at 12/24/36/48 months was 100/89/72/72% for all tumors, 100/93/79/79% for Grade II, and 100/50/0/0% for Grade III, respectively. No patient receiving STaRT as their initial RT failed. Median overall survival was 50 months. Four symptomatic adverse events occurred, 2 wound breakdowns requiring surgery and 2 radiation-related brain changes, medically treated. CONCLUSION R+STaRT demonstrates favorable safety and LC outcomes in this single-arm prospective trial that includes heavily pre-treated patients. A commercial version of the device recently received FDA clearance for use in newly diagnosed malignant or recurrent intracranial neoplasms including meningiomas.

Background The trial collected prospective data from physiology measurements of borderline lesions in five Czech, one Japan and one Argentinian cathlabs. The main purposes were to analyze diagnostic agreement between FFR (fractional flow reserve) and iFR (instantaneous wave free ratio) examinations and to find possible explanations for discrepant results. Methods FFR and iFR examinations were analyzed using Philips-Volcano console and coronary flow reserve (CFR) was analyzed by using Combomap machine Philips-Volcano. Hyperemia for FFR and CFR measurements was induced by intracoronary administration of adenosine. We used CFR as a truth for comparison between FFR and iFR, because CFR has higher impact on patients prognosis than pressures indices. Results Data were collected from February 2016 to June 2019 and the database includes 1.789 examinations from 1.492 patients (282 of them, 15.8%, with ACS). CFR were measured in 343 lesions in 293 patients. (ACS 31.2%). Overall correlation between FFR and iFR is high (R=0.86 p Conclusion The FFR/iFR discrepancy occurred in almost one quarter of examinations. Correlation between CFR and iFR is better than between CFR and FFR. High flow is probably one of the main reason for FFRp/iFRn type of discrepancy. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Czech Health Research Council

Cerebral venous outflow disturbance (CVOD) has begun to garner the attention of researches owing to a series of clinical symptoms that impose a significant impact on people's quality of life. Herein, we aimed to investigate whether normobaric oxygen (NBO) can ameliorate CVOD-induced neurological symptoms. This was one part of the prospective trial registered in ClinicalTrials.gov (NCT03373292). A total of 37 CVOD patients were divided into the NBO group (5–8 L/min of oxygen inhalation, 1 h per time, 3 times daily, n = 19) and the control group (without oxygen inhalation, n = 18) randomly. The assessments were performed at admission, 1-week hospitalization, and 6-month follow-up. Quantitative electroencephalogram (qEEG) data were recorded prior to and post 1 h of NBO in some patients. R software was used for data analysis. No NBO-related adverse events were observed during the whole NBO intervention process. The 1-week Patient Global Impression of Change (PGIC) scale showed that the symptom improvement occurred in nine patients in the NBO group (47.4%) while none in the control group (p = 0.001). NBO could improve headache evaluated with visual analog scale (pre-NBO vs. post-NBO: 4.70 ± 2.16 vs. 2.90 ± 2.03, p = 0.024) and Headache Impact Test-6 (53.40 ± 12.15 vs. 50.30 ± 13.04, p = 0.041). As for 6-month PGIC follow-up, eight out of 14 cases (57.1%) in the NBO group reported improvement, while only one out of 12 patients in the control group replied mild improvement (p = 0.014). The qEEG revealed that NBO reduced the ratio of theta to alpha power (0.65 ± 0.38 vs. 0.56 ± 0.35, p = 0.030) over the fronto-central electrodes. To sum up, NBO may be a safe and effective approach to attenuate CVOD-related symptoms (especially for headache) by brain functional improvement resulting from increasing oxygen supply to the brain tissues.

Background: Achieving higher yields in solitary pulmonary nodule (SPN) diagnosis has been demonstrated by combining multiple modalities. Radial probe endobronchial ultrasound (R-EBUS) has been routinely utilized to safely identify SPNs for sampling in order to increase yields. Archimedes® virtual bronchoscopic navigation (VBN) system is a diagnostic modality to access and sample SPNs under fused-fluoroscopic guidance. Aim: To compare biopsy yield and performance of VBN system with and without confirmation by R-EBUS prior to sampling. Methods: A total of 100 patients with SPN ≥8 mm completed transbronchial biopsy (TBB) procedure in 10 hospitals. Patients were registered to align the CT with the live fluoroscopic view. The scope was navigated to create an access path to the SPN using the VBN system and R-EBUS was added in certain TBB procedures to confirm the SPN location. Biopsy forceps +/- needle were applied under fluoroscopic guidance to obtain tissue samples. Results: A data summary of 102 biopsied SPNs is presented in the table. Value is reported in median (interquartile range [quartile1-quartile3]) (Fig. 1). Conclusion: Higher yield for VBN alone suggests combination with R-EBUS may be beneficial under certain circumstances but not necessarily required for all procedures.

Objective Talc slurry pleurodesis (TSP) can lead to permanent small loculations. Intrapleural tissue plasminogen activator (tPA) breaks down loculations, and therefore may improve results but may also inhibit pleurodesis. tPA was given with and after talc slurry to promote more uniform talc distribution and eliminate loculations. Methods Charts were reviewed for patients treated with TSP with or without tPA. Chest x-rays after TSP were compared to chest x-rays before and graded as "worse", "same", or "better". Incidence of need for repeat TSP was recorded. Results There were 52 patients, eight with bilateral effusions, for a study cohort of 60 effusions. One-third of the effusions were malignant. No patients experienced significant bleeding. Results were better than baseline for 14 (26%) patients given tPA, but not for patients that never received tPA. The addition of tPA 4-6 mg with talc slurry resulted in no patients requiring repeat TSP. When tPA was given after talc slurry, a delay of three days was associated with the lowest incidence of repeat TSP (3/14, 21%). Conclusions There were no significant complications from tPA use to supplement TSP, and tPA may improve results without interfering with pleurodesis. A prospective trial is warranted.

Purpose The German Classification of Diverticular Disease was introduced a few years ago. The aim of this study was to determine whether Classification of Diverticular Disease enables an exact stratification of different types of diverticular disease in terms of course and treatment. Methods This was a prospective, bicentric observational trial. Patients aged ≥ 18 years with diverticular disease were prospectively included. The primary endpoint was the rate of recurrence within 2 year follow-up. Secondary outcome measures were Gastrointestinal Quality of Life Index, Quality of life measured by SF-36, frequency of gastrointestinal complaints, and postoperative complications. Results A total of 172 patients were included. After conservative management, 40% of patients required surgery for recurrence in type 1b vs. 80% in type 2a/b (p = 0.04). Sixty percent of patients with type 2a (micro-abscess) were in need of surgery for recurrence vs. 100% of patients with type 2b (macro-abscess) (p = 0.11). Patients with type 2a reached 123 ± 15 points in the Gastrointestinal Quality of Life Index compared with 111 ± 14 in type 2b (p = 0.05) and higher scores in the “Mental Component Summary” scale of SF-36 (52 ± 10 vs. 43 ± 13; p = 0.04). Patients with recurrent diverticulitis without complications (type 3b) had less often painful constipation (30% vs. 73%; p = 0.006) when they were operated compared with conservative treatment. Conclusion Differentiation into type 2a and 2b based on abscess size seems reasonable as patients with type 2b required surgery while patients with type 2a may be treated conservatively. Sigmoid colectomy in patients with type 3b seems to have gastrointestinal complaints during long-term follow-up. Trial registration https://www.drks.de ID: DRKS00005576

Background and study aims Esophagogastric junction outflow obstruction (EGJOO) is a rare esophageal dysmotility disease that is characterized by elevated integrated relaxation pressuse (IRP) with evidence of preserved peristalsis. The role of peroral endoscopic myotomy (POEM) in management of EGJOO is currently unknown. Patients and methods This is a prospective trial conducted in a single US tertiary care center from June 2015 to June 2019. Symptomatic patients, diagnosed with EGJOO on both HRM and endoluminal functional lumen imaging probe (EndoFLIP), who were eligible for POEM were recruited. Primary outcome was clinical success, defined as Eckardt score (ES) ≤ 3, at 6 months post-POEM. Other outcomes included dysphagia score, quality of life as measured by 36-item Short Form health survey scales (SF-36), post-POEM HRM, EndoFLIP, and pH measurements, and adverse events. Results A total of 15 patients (51.8 yr. 9 F) with EGJOO underwent POEM. Pre-POEM mean IRP on HRM and Distensibility index (DI) on EndoFLIP were 24.3 ± 2.2 mmHg and 1.1 ± 0.6 mm2/mmHg, respectively. Clinical success was achieved in 93 % at 6 months post-POEM. There was significant decrease in IRP (-17.6 mmHg) post-POEM. There was significant improvement at 6 months in two of the SF-36 subscales. Ten patients underwent post-POEM pH testing, seven of whom had abnormal DeMeester score. Seven patients underwent EGD evaluation revealing esophagitis in five (2 Los Angeles grade A and 3 grade B). Conclusions POEM offers a high clinical success rate for patients with EGJOO confirmed by impedance planimetry.

To evaluate the functional and anatomical outcomes of a treat-and-extend (TAE) regimen with aflibercept for treatment-naive macular edema (ME) secondary to branch retinal vein occlusion (BRVO). This was a prospective, multicenter, noncomparative, open-label clinical trial. Forty-eight eyes of 48 patients received three monthly intravitreal aflibercept injections prior to the TAE regimen. However, if the best-corrected visual acuity (BCVA) was ≥ 20/20 and the central macular thickness (CMT) was < 250 μm during the loading phase, the patient immediately proceeded to the TAE regimen. The treatment interval was adjusted by 4 weeks based on changes in CMT. The primary outcome was the mean change in BCVA from baseline to 52 weeks. The mean change in BCVA was 23.6 ± 14.2 letters. The proportion of patients with BCVA gain ≥ 15 letters was 77.1% at 24 weeks and 72.9% at 52 weeks. The mean reduction in CMT was 326.2 ± 235.6 μm at 24 weeks and 324.2 ± 238.0 μm at 52 weeks. The mean number of injections was 6.7 ± 1.2 (range: 6–11, all patients received three monthly intravitreal aflibercept injections) over 52 weeks, and 34 patients (70.8%) reached the maximal extension interval of 16 weeks at 52 weeks. The TAE regimen using aflibercept for ME secondary to BRVO, which has a treatment interval of up to 16 weeks, showed comparable efficacy to the fixed-dosing regimen along with reduced treatment burden.

Aim: Genomic-based risk stratification to personalize radiation dose in rectal cancer. Patients & methods: We modeled genomic-based radiation dose response using the previously validated radiosensitivity index (RSI) and the clinically actionable genomic-adjusted radiation dose. Results: RSI of rectal cancer ranged from 0.19 to 0.81 in a bimodal distribution. A pathologic complete response rate of 21% was achieved in tumors with an RSI

Sevoflurane is an inhaled anesthetic widely used for pediatric anesthesia, but emergence agitation (EA) or emergence delirium (ED) is a common sevoflurane anesthesia recovery-associated problem.1 Emergence agitation is associated with increased risk of injury in children and parents' dissatisfaction with anesthesia care.2 In a web-based survey of pediatric anesthesiologists in Canadian Pediatric Anesthesia Society, 42% felt that EA was a significant problem and 45% of them were giving medication before or during anesthesia to prevent its development.

Background: Retrospective studies have suggested that chemotherapy-induced leukopenia is associated with improved recurrence-free or overall survival. The SBG 2000–1 trial was designed to verify the favorable prognosis associated with chemotherapy-induced leukopenia in early breast cancer. Patients not experiencing chemotherapy-induced leukopenia were randomized into standard dosed or individually escalated chemotherapy doses based on the grade of leukopenia after a first standard dose. Patients and methods: 1452 women in Sweden and Denmark with operable node-positive or high-risk node-negative breast cancer aged 18–60 years were recruited to participate in this trial. Participants received a first FEC cycle at standard doses (600/60/600 mg/m2). Patients (n = 1052) with nadir leukopenia grade 0–2 after the first cycle were randomized between either 6 standard FEC or 6 tailored FEC courses with doses of epirubicin and cyclophosphamide escalated during courses 2 and 3 and thereafter aimed at achieving grade 3 leukopenia. Patients with nadir leukopenia grade 3–4 after the first course continued treatment with standard FEC. Results of the randomized comparison has been published previously. The present study focuses on chemotherapy-induced leukopenia as a covariable with outcome in randomized and non-randomized patients. The prognostic value of leukopenia after course 3, was studied in a Cox model adjusted for cumulative doses of epirubicin and cyclophosphamide. The association of chemotherapy-induced leukopenia with prognosis was a preplanned secondary endpoint for this trial. Results: The eight-year distant disease-free survival was 73%, 77%, 78% and 83% for patients with leucocyte nadir grade 0, 1, 2 and 3–4, respectively. Higher degree of leukopenia was highly significantly associated to improved distant disease-free survival (HR 0.84, 95% CI 0.74–0.96, p =.008) and overall survival (HR 0.87 (0.76–0.99, p =.032). Conclusion: This prospective study confirms that chemotherapy-induced leukopenia is a covariable with outcome in primary breast cancer, even after adjustment for chemotherapy doses.

BACKGROUND As dermatofibrosarcoma protuberans (DFSP) are rare with no prospective series within paediatric sarcoma trials, the European Paediatric Soft Tissue Sarcoma Study Group (EpSSG) examined the clinical data and outcomes of DFSP enrolled in a multinational study of non-rhabdomyosarcoma soft tissue sarcomas (NRSTS). PATIENTS AND METHODS Forty-six patients with confirmed DFSP were enrolled into the EpSSG NRSTS 2005 study. All had surgical resection and none had any further therapy at diagnosis. RESULTS The median age at diagnosis was 6.9 years (range 0.4-17.5). All patients had localised disease, and the majority had small

Objective: The objective of the study was to identify the failure rate of insertion of ureteral access sheath (UAS) during primary flexible ureteroscopy (FURS). Materials and Methods: This was a single-surgeon, single-tertiary care center retrospective study. All patients who underwent primary FURS for proximal ureteric or renal stones from November 2014 to May 2018 were included in the study. Patients with a stone burden of more than 20 mm were excluded from the study. A 10/12-Fr coaxial UAS (Bi-Flex, Rocamed) was used. Data collection included age, sex, body mass index (BMI), stone burden and location, previous spontaneous passage of stones, type of anesthesia, and preexisting congenital anomalies. The Chi-square test and t-test were used for the statistical analyses. Results: One hundred and twelve patients were included in the study. All patients underwent primary FURS. The failure rate of primary UAS insertion was 10.7% (n = 12). No statistically significant difference was found in age, BMI, type of anesthesia, previous history of spontaneous stone passage, and stone burden between the success and failure groups (P > 0.05). Conclusions: We believe that our study opens the door for a multicentric prospective trial. Identifying factors leading to a failed primary FURS and UAS insertion is crucial to properly counsel patients preoperatively about the number of procedures that they might need and to prevent the financial loss associated with failed UAS insertion.

Aims: Studies have demonstrated that CGM can improve HbA1C and reduce glucose variability in individuals with type 1 diabetes (T1D). We aim to assess the efficacy of flash glucose technology on glycemic accuracy control in T1D by lifestyle and/or medication modification and to use the CGM time in range (TIR) as outcomes of measures. Methods: The program is a multicenter, prospective, RCT enrolled adults from 5 Chinese diabetes centers. Individuals were eligible to participate if they had T1D and were deemed technically capable of using flash glucose technology. All participants had no experience with Flash before participating the study and received the education of diabetes self-care at baseline. Based on the glucose reports, dietary, excise and insulin therapy changes were made by self-care behaviors. Data from 153 adults who using flash glucose monitoring for 12 weeks were analyzed. Results: After 153 participants who had no experience with flash used flash for 12 weeks, HbA1C was reduced from (7.96± 1.78) % at baseline to (7.54±1.20) % at 12 weeks (P250 drop from 12.65% to 7.77%, with a concurrent decrease in TBR54-69 from 9.96% to 8.31% and TBR Conclusion: T1D patients who had no experience with flash achieved a better glycemic profile from the flash glucose monitoring. Flash glucose technology is useful for improving glycemic control of T1D patients by changes to patient’s lifestyle and/or insulin therapy. Disclosure L. Guo: None. M. Zhang: None. H. Kuang: None. Y. Li: None. X. Xiao: None. X. Jia: None. T. Yang: None.

Purpose: To investigate the effect of prophylactic use of SafeSkin films strips applied to the inframammary fold during whole breast or reconstructed breast irradiation to avoid moist desquamation to the inframammary fold. Materials and Methods: Between November 15, 2016 and April 17, 2018, a total of 30 patients were recruited, with 29 patients contributing to analysis, and one patient with bilateral breast cancer. Areas of the breast treatment field not covered by the film were treated with physician's choice of cream, (80% Jean's Cream, 13% Aquafor, and 7% with no topical therapy). The treatment field was photographed weekly. SkinSafe strips were reapplied as needed, but were not applied if erythema was already observed in the inframammary fold. Severity of skin reaction was assessed using the RTOG scale. Results: There was only one treatment interruption, against medical advice, due to axillary discomfort. One patient refused further trial participation after the first day. No short or long term side effects of film use were noted. Inframammary desquamation developed in only one patient, who tried to replicate the increased comfort of her inframammary tape with adhesive bandages when her tape came off. There was no moist desquamation under the SkinSafe film in the inframammary field in any patient. Axillary moist desquamation, where no film, but rather physician's choice of topical cream was applied, remained at 35%. Areas of skin adjacent to the SkinSafe film showed desquamation in 9.7% of patients, 0.5-1 cm in maximal diameter, all of which had resolved at time of completion. Conclusions: Prophylactic use of SkinSafe film strips applied to the inframammary fold substantially reduces or eliminates the risk of inframammary desquamation during breast radiation. Citation Format: Garren D, Le B, Vasireddy R, Flynn L, Forster K, Malina L, Dorfman Y. Prophylactic application of SkinSafe film strips to the inframammary fold prevents moist desquamation during irradiation for breast cancer in a prospective trial [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P3-12-11.

We sought to characterize the angiofibrotic and apoptotic effects of vascular endothelial growth factor (VEGF)-inhibition on fibrovascular epiretinal membranes in eyes with traction retinal detachment because of proliferative diabetic retinopathy.Membranes were excised from 20 eyes of 19 patients (10 randomized to intravitreal bevacizumab, 10 controls) at vitrectomy. Membranes were stained with antibodies targeting connective tissue growth factor (CTGF) or VEGF and colabeled with antibodies directed against endothelial cells (CD31), myofibroblasts, or retinal pigment epithelium markers. Quantitative and colocalization analyses of antibody labeling were obtained through immunofluorescence confocal microscopy. Masson trichrome staining, cell counting of hematoxylin and eosin sections, and terminal dUTP nick-end labeling staining were performed.High levels of fibrosis were observed in both groups. Cell apoptosis was higher (P = 0.05) in bevacizumab-treated membranes compared with controls. The bevacizumab group had a nonsignificant reduction in colocalization in CD31-CTGF and cytokeratin-VEGF studies compared with controls. Vascular endothelial growth factor in extracted membranes was positively correlated with vitreous levels of VEGF; CTGF in extracted membranes was negatively correlated with vitreous levels of CTGF.Bevacizumab suppresses vitreous VEGF levels, but does not significantly alter VEGF or CTGF in diabetic membranes that may be explained by high baseline levels of fibrosis. Bevacizumab may cause apoptosis within fibrovascular membranes.

Background The double lumen endotracheal tube (DLT) is the most widely-used device for single lung ventilation in current thoracic anesthesia practice. In recent years, the routine application of the videolaryngoscope for single lumen endotracheal intubation has increased; nevertheless there are few studies of the use of the videolaryngoscope for DLT. We wondered whether there were benefits to using the videolaryngoscope for DLT placement in patients with predicted normal airways. Therefore, this study was designed to compare the performances of the GlideScope®, the C-MAC®(D) videolaryngoscope and the Macintosh laryngoscope in DLT intubation. Methods This was a randomized, controlled, prospective study. We randomly allocated 90 adult patients with predicted normal airways into three groups. All patients underwent routine anesthesia using different laryngoscopes according to group allocation. We compared DLT insertion times, first-pass success rates, numerical rating scales (NRS) of DLT delivery and DLT insertion, Cormack-Lehane degrees (C/L), hemodynamic changes and incidences of intubation complications. All outcomes were analyzed using SPSS13.0. Results Compared with the GlideScope, the Macintosh gave shorter times for DLT insertion (median: 96 (IQR: 51 [min–max: 62–376] s vs 73 (26 [48–419] s, p = 0.003); however, there was no difference between the Macintosh and C-MAC(D) (p = 0.610). The Macintosh had a significantly higher successful first attempt rate than did the GlideScope or C-MAC(D) (p = 0.001, p = 0.028, respectively). NRS of DLT delivery and insertion were significantly lower in the Macintosh than in the others (p p > 0.05). There were no significant differences in DLT misplacement, fiberoptic time or hemodynamic changes among the groups. Conclusions Compared with the Macintosh laryngoscope, the GlideScope® and C-MAC®(D) videolaryngoscopes may not be recommended as the first choice for routine DLT intubation in patients with predicted normal airways. Trial registration The study was prospectively registered at the Chinese Clinical Trial Registry (no. ChiCTR1900025718); principal investigator: Z.L.H.; date of registration: September 6, 2019.

Background and Aims: This study aims to evaluate the analgesic effect of ultrasound-guided erector spinae plane block (ESPB) in paediatric lower abdominal surgeries. Methods: Randomised, prospective trial. Forty patients, aged 2–10 years with the American Society of Anesthesiologists Score of I and II scheduled for elective lower abdominal surgery were included in the study. Interventions: Patients were randomised into two groups as control group and ESPB group. Ultrasound-guided erector spinae plane block at L1 vertebral level was performed preoperatively using 0.5 ml/kg 0.25% bupivacaine (max 20 ml) for the patients in ESPB group. Analgesic requirements and time to first analgesic requirement were recorded and Face, Legs, Activity, Cry and Consolability (FLACC) scores for pain were recorded at 0, 1, 2, 3, 6, 12 and 24 h postoperatively. Results: Forty patients were included in the final analyses. Significant difference was determined between the groups on post-operative morphine requirement and FLACC scores at 3 h and 6 h postoperatively (P < 0.05). Significant difference was also determined in time to first dose of rescue analgesia between the groups (P < 0.05). Conclusions: This study shows that the ESPB provides adequate post-operative analgesia in paediatric patients undergoing lower abdominal surgery.

Contaminated surfaces in a hospital serve as reservoirs for pathogen spread. The aim of this study was to evaluate UV lights in preventing the spread of a DNA tracer in an intensive care unit (ICU) through sterilization of highly touched surfaces. In a prospective trial, a non-pathogenic DNA virus was inoculated onto surfaces in an ICU patient room. Investigators swabbed frequently touched surfaces in non-inoculated ICU rooms at 24, 48, and 96 h post inoculation. Culture specimens were analyzed for the presence of viral DNA via PCR. After baseline data were obtained, UV lights were deployed in a standardized fashion onto vitals monitors, ventilators, keyboards, and intravenous (IV) pumps. Inoculation and culturing were then repeated. Prior to UV implementation, the DNA tracer disseminated to 10.10% of tested surfaces in non-inoculated rooms at 48 h. Post UV light deployment, only 1.20% of surfaces tested positive for the DNA tracer after 48 h. UV decontamination significantly retarded the spread of the virus DNA, with a relative reduction of 90% at 48 h from 10.10% of surfaces pre UV to 1.20% of surfaces post UV (p &lt, 0.0001). UV decontamination holds the potential to confer protection to patients by reducing the number of surfaces that can serve as a nidus for transfer.