Search

Introduction: Pregnant women with mechanical prosthetic heart valves (MPHV) are reportedly at high risk of mortality and morbidity. We aimed to compare outcomes at our specialist centre with national data, and whether anticoagulation regimes influenced outcome. Methods: We conducted a retrospective cross-sectional study of all pregnant women with MPHV managed by our service between 2003-2021. Maternal and fetal outcomes and anticoagulation data were collected. Summary statistics and comparative analysis with results from the national UK-wide dataset were compiled. Results: A total of 50 pregnancies in 23 women were identified. Patients with complex valve replacements were common, with 34.8% of pregnancies involving management of dual MPHV. Maternal mortality was zero (95% CI: 0-7.1). Serious maternal and obstetric complications occurred in only 7 pregnancies (14.0%; 95% CI: 7.0-26.2%), including only two valve thromboses (4%). Live births followed 31 of the pregnancies (62%), compared with a national baseline of ~75%. Low molecular weight heparin was the most commonly used anticoagulant during pregnancy (84%), but no single anticoagulation regime was found to be universally optimal. Concomitant low-dose aspirin was given to those with dual or systemic mechanical atrioventricular valve replacement. Discussion: Our study is the largest single centre report on maternal outcome for women with MPHV. We share how comprehensive, multidisciplinary planning may significantly reduce mortality and morbidity for our patients. Anticoagulation management should be individualised according to patient risk profile. With appropriate peripartum care, risk for women with MPHV considering pregnancy may be lower than previously reported

Pregnancy is a hypercoaguable state. As part of the multidisciplinary team on labour ward, the anaesthetist plays a role particularly in advising the women and the obstetric team regarding the timing and even choice of regional analgesia given the potential risk of complications, as this may be affected by the anticoagulation treatment pregnant women may be on. It is important to understand the type of anticoagulation regimens parturients might be on and what sort of risk assessment they must undergo, as this has obstetric and anaesthetic implications. Although a rare presentation, management of women with mechanical prosthetic heart valves who are pregnant requires detailed and highly specialised care in tertiary care centres with a well-developed multidisciplinary team and pathway. Despite their rare presentation, it is important to understand the intricate and complex management that these women require as they have a high morbidity and mortality rate.

Background The role of high flow nasal oxygenation (HFNO) for pre-oxygenation before obstetric general anaesthesia remains unclear. This study aimed to determine the number of vital capacity breaths using HFNO required to pre-oxygenate 90% of parturients to an end-tidal oxygen concentration fraction (FETO2) of ≥0.90 (termed EN90). Methods Using up-down, sequential allocation trial design, volunteer term parturients undergoing caesarean delivery were investigated with HFNO with their mouth closed, followed by mouth open, and if FETO2 ≥0.90 was not achieved after a maximum of 20 vital capacity breaths, pre-oxygenation was attempted with a face mask. The primary outcome was the number of vital capacity breaths required using HFNO (mouth open and closed) to achieve EN90. Secondary outcomes included assessment of EN90 using mouth open versus mouth closed and face mask pre-oxygenation, maternal satisfaction and evaluation of fetal cardiotocography. Results Twenty women at term were recruited. Successful pre-oxygenation occurred in 4 (20%), 3 (15%) and 14 (70%) women with HFNO mouth closed, HFNO mouth open, and via face mask respectively. At up to 20 vital capacity breaths, face mask pre-oxygenation was more successful at achieving EN90 compared with both HFNO with a closed (P=0.006) or open (P=0.001) mouth. Closed mouth HFNO did not outperform open mouth pre-oxygenation. Conclusion Face mask pre-oxygenation is more effective at achieving EN90 compared with to HFNO within a clinically acceptable number of vital capacity breaths. Further studies are needed to determine the role of HFNO in optimising the time before desaturation and for apnoeic oxygenation in term parturients.

BackgroundPreoperative risk factor identification and optimisation are widely accepted as the gold standard of care for elective surgery and are essential for reducing morbidity and mortality. COVID-19 public health restrictions required a careful balance between ensuring best medical practices and maintaining safety by minimising patient face-to-face attendance in the hospital. Based on the successful implementation of telemedicine (TM) in other medical specialties and its feasibility in the preoperative context, this study aimed to develop, implement and evaluate a high-quality virtual preoperative anaesthetic assessment process.MethodsThe three-step model for improvement was used. The specific, measurable, actionable, relevant, time aim (step 1) and measures for improvement (step 2) were defined at the onset of the project. The plan–do–study–act tool was used for the structured implementation of improvement interventions (step 3) in three phases. Data relating to virtual and in-person referrals, assessments, did-not-attend (DNA) rate, consultation time, day of surgery delays and cancellations, and service-user and provider experience surveys were recorded prospectively.ResultsA total of 2805 patients were assessed in the preoperative anaesthetic assessment clinic between July 2020 and March 2021. The mean rate of virtual preoperative assessments was 50% (SD ±10) (1390/2805). 0.1% (30/2805) were inappropriately referred on the alternative pathway. The DNA rate was 0.4% (8/1398) and 3% (43/1458) for virtual and in-person pathways, respectively. The mean consultation times for virtual and in-person attendance were 19 (SD ±7) and 31 (SD ±13) min, respectively. There were five same-day surgery cancellations and one delay due to medical reasons. When asked about their experience with the virtual assessment, both service users and providers reported high satisfaction, minimal technical difficulties and shared concerns about limited opportunities for physical examination.ConclusionThis is one of the first implementational studies to comprehensively outline the feasibility of TM in preoperative anaesthetic assessment during COVID-19.

COVID-19, the respiratory disease caused by SARS-CoV-2, is thought to cause a milder illness in pregnancy with a greater proportion of asymptomatic carriers. This has important implications for the risk of patient-to-staff, staff-to-staff and staff-to-patient transmission among health professionals in maternity units. The aim of this study was to investigate the prevalence of previously undiagnosed SARS-CoV-2 infection in health professionals from two tertiary-level maternity units in London, UK, and to determine associations between healthcare workers' characteristics, reported symptoms and serological evidence of prior SARS-CoV-2 infection. In total, 200 anaesthetists, midwives and obstetricians, with no previously confirmed diagnosis of COVID-19, were tested for immune seroconversion using laboratory IgG assays. Comprehensive symptom and medical histories were also collected. Five out of 40 (12.5%; 95%CI 4.2-26.8%) anaesthetists, 7/52 (13.5%; 95%CI 5.6-25.8%) obstetricians and 17/108 (15.7%; 95%CI 9.5-24.0%) midwives were seropositive, with an overall total of 29/200 (14.5%; 95%CI 9.9-20.1%) of maternity healthcare workers testing positive for IgG antibodies against SARS-CoV-2. Of those who had seroconverted, 10/29 (35.5%) were completely asymptomatic. Fever or cough were only present in 6/29 (21%) and 10/29 (35%) respectively. Anosmia was the most common symptom occurring in 15/29 (52%) seropositive participants and was the only symptom that was predictive of positive seroconversion (OR 18; 95%CI 6-55). Of those who were seropositive, 59% had not self-isolated at any point and continued to provide patient care in the hospital setting. This is the largest study of baseline immune seroconversion in maternity healthcare workers conducted to date and reveals that one out of six were seropositive, of whom one out of three were asymptomatic. This has significant implications for the risk of occupational transmission of SARS-CoV-2 for both staff and patients in maternity units. Regular testing of staff, including asymptomatic staff should be considered to reduce transmission risk.

Caesarean delivery is the most commonly performed inpatient surgical procedure globally. Pain after caesarean delivery is moderate to severe if not adequately treated, and is a primary anaesthetic concern for patients. Transversus abdominis plane and quadratus lumborum blocks are fascial plane blocks that have the potential to improve analgesia following caesarean delivery. Although proponents of the quadratus lumborum block suggest that this technique may provide better analgesia compared with transversus abdominis plane block, there are limited data directly comparing these two techniques. We, therefore, performed a systematic review and network meta-analysis to compare transversus abdominis plane and quadratus lumborum block approaches, seeking randomised controlled trials comparing both techniques to each other, or to control, with or without intrathecal morphine. In all, 31 trials with 2188 patients were included and our primary outcome, the cumulative intravenous morphine equivalent consumption at 24 h, was reported in 12 trials. In the absence of intrathecal morphine, transversus abdominis plane and quadratus lumborum blocks were equivalent, and both were superior to control (moderate-quality evidence). In the presence of intrathecal morphine, no differences were found between control, transversus abdominis plane and quadratus lumborum blocks (moderate-quality evidence). Similar results were found for resting and active pain scores at 4-6 h, 8-12 h, 24 h and 36 h, although quadratus lumborum block was associated with lower pain scores at 36 h when compared with transversus abdominis plane block (very low-quality evidence). However, transversus abdominis plane block was associated with a reduced incidence of postoperative nausea and vomiting (moderate-quality evidence) and sedation when compared with inactive control following intrathecal morphine administration (low-quality evidence). There are insufficient data to draw definitive conclusions, but transversus abdominis plane and quadratus lumborum block appear to be superior to control in the absence of intrathecal morphine, but provide limited additional benefit over inactive control when intrathecal morphine is also used.

Levobupivacaine is a long-acting amide local anaesthetic used in analgesia and anaesthesia. Like other local anaesthetic drugs, levobupivacaine exhibits effects on motor and sensory nerves by inhibiting the opening of voltage-gated sodium channels, and hence propagation of neuronal action potentials. Levobupivacaine is the S(-) stereoisomer of dextrobupivacaine, although both are used commercially in the racemic form bupivacaine. A favourable safety and drug effect profile for levobupivacaine has led to widespread use. Levobupivacaine is generally well tolerated but dose adjustment is important in populations such as paediatrics and the elderly. The pharmacokinetic properties of levobupivacaine are similar to that of bupivacaine; both extensively metabolised in the liver, and excreted in the urine and faeces. In vitro, animal model and human studies confirm a lower risk of cardiac and central nervous system toxicity with levobupivacaine compared with bupivacaine. Clinical trials of relative potency are impaired by the variability in chosen endpoints for sensory and motor function blockade, but clinically significant differences in potency are minor, with most clinical trials showing similar duration and quality of anaesthesia between levo- and racemic bupivacaine. In practice, levobupivacaine is most commonly used in regional anaesthesia, neuraxial anaesthesia and local infiltration analgesia. This review includes an appraisal of evidence from clinical trials of the pharmacokinetic and pharmacodynamic properties of levobupivacaine.

Background Enhanced recovery protocols for caesarean section have been introduced in many maternity units with the aim of improving clinical outcomes and improving service efficiency. Aim Our aim was to assess the available evidence for the efficacy of enhanced recovery protocols for elective caesarean section compared to conventional care. Materials and methods A systematic review was performed through a search of MEDLINE, EMBASE, The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials Database. Results After screening 118 records and reviewing 38 articles, no studies met the inclusion criteria for this systematic review. However, from ten articles we were able to describe 29 individual interventions that are included in the enhanced recovery pathways of care for elective caesarean sections. Early reintroduction of fluids and food was the only intervention that was common to all pathways. Conclusion This review reveals that while the adoption of enhanced recovery pathways for caesarean sections is increasing, there remains a paucity of evidence in the published literature on outcomes. This is reflected in the significant heterogeneity of the individual components included in various pathways currently in practice. Furthermore, development of standardised outcome metrics is required to facilitate meaningful comparison of multiple interventions. Further well-designed research is needed to properly assess the potential benefits of these interventions to improve maternal outcomes after obstetric surgery.

Objective Maternal hemodynamics change significantly during Cesarean section complicated by massive hemorrhage or severe hypertensive disease. Cardiac output (CO) monitoring aids early, goal-directed hemodynamic therapy. The aim of this study was to record hemodynamic changes observed during Cesarean section in pregnancies at high risk of hemodynamic instability, using invasive (LiDCOrapid™) and non-invasive (NICOM®) devices, and to assess agreement between the two devices in measuring CO. Methods Simultaneous intraoperative hemodynamic measurements were taken using the LiDCOrapid and NICOM devices, following standardized techniques, in women at high risk of hemodynamic instability undergoing Cesarean section. Agreement in CO measurements between the two devices was assessed using Bland-Altman plots and the agreement:tolerability index (ATI). Agreement analyses were performed for repeated measures in subjects, using centiles. Results From 10 women, 307 paired measurements were analyzed. Mean bias (defined as the mean difference in CO measurements between the LiDCOrapid and NICOM devices) was 3.05 (95% CI, 1.89 to 4.21) L/min. Limits of agreement ranged from -1.58 (95% CI, -4.47 to -0.14) to 7.68 (95% CI, 6.24 to 10.56) L/min. The resulting agreement interval was 9.26 L/min which returned an ATI of 2.3. Conclusions There are large mean differences between CO measurements obtained during Cesarean section using the LiDCOrapid and NICOM hemodynamic monitors in pregnant women at high risk of hemodynamic instability, indicating that they should not be considered interchangeable clinically. There is an unacceptably low level of agreement (ATI > 2) in CO measurements between the devices, conferring a high risk of clinical misclassification during massive hemorrhage. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

Background Higher-risk surgical patients may not be admitted to the intensive care unit due to stable immediate post-operative status on review. The outcomes of this cohort are not well described. Our aim was to examine the subsequent inpatient course of intensive care unit -referred but not admitted surgical patients. Methods All patients aged ≥18 years who were referred but not admitted for post-operative management in a tertiary metropolitan intensive care unit following non-cardiac surgery between 1/7/2017 and 30/6/2018 were eligible for inclusion in this retrospective observational cohort study. Primary outcome was Medical Emergency Team activation. Secondary outcomes included unplanned intensive care unit admission; length of stay; and 30-day mortality. Risk of serious complications and predicted length of stay were calculated using the National Surgical Quality Improvement Program scoring tool. Results Fifteen of 60 patients (25%) had a MET-call following surgery, eight (13%) patients required unplanned intensive care unit admission, with median (IQR) time to Medical Emergency Team call 9 (6–13) hours. No patients died within 30-days. There was no significant difference between mean National Surgical Quality Improvement Program predicted and actual length of stay; after adjustment, National Surgical Quality Improvement Program predicted risk of serious complications was associated with unplanned intensive care unit admission (OR [95% CI] = 1.08 [1.00–1.16], p = 0.04), although not Medical Emergency Team calls. Conclusions Post-operative deterioration occurs frequently, and early, in a cohort of high-risk surgical patients initially assessed as being safe for ward care. Changes to current triage models for post-operative intensive care unit admission may reduce the impact of complications in this high-risk group.

The world is currently facing an unprecedented healthcare crisis caused by a pandemic novel beta coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The pathogen is spread by human-to-human transmission via droplets exposure and contact transfer, causing mild symptoms in the majority of cases, but critical illness, bilateral viral pneumonia, and acute respiratory distress syndrome (ARDS) in a minority. Currently, controlling infection to prevent the spread of SARS-CoV-2 is the primary public healthcare intervention used. The pace of transmission and global scale of SARS-CoV-2 infections has implications for strategic oversight, resource management, and responsiveness in infection control. This article presents a summary of learning points in epidemiological infection control from the SARS epidemic, alongside a review of evidence connecting current understanding of the virologic and environmental contamination properties of SARS-CoV-2. We present suggestions for how personal protective equipment policies relate to the viral pandemic context and how the risk of transmission by and to anaesthetists, intensivists, and other healthcare workers can be minimised.

SummaryCOVID-19, the respiratory disease caused by the SARS-CoV-2, is thought to cause a milder illness in pregnancy with a greater proportion of asymptomatic carriers. This has important implications for the risk of patient-to-staff, staff-to-staff and staff-to patient transmission among health professionals in maternity. The aim of this study was to investigate the prevalence of previously undiagnosed SARS-CoV-2 infection in health professionals from two tertiary-level maternity units in London, UK and to determine associations between HCW characteristics, reported symptoms and serological evidence of prior SARS-CoV-2 infection.200 anaesthetists, midwives and obstetricians with no previously confirmed diagnosis of COVID-19 were tested for immune seroconversion using laboratory IgG assays. Comprehensive symptom and medical histories were also collected. 5/40 (12.5%; 95% CI: 4.2-26.8) anaesthetists, 7/52 (13.5%; 95% CI: 5.6-25.8%) obstetricians and 17/108 (15.7%; 95% CI: 9.5-24.0%) midwives were seropositive, with an overall total of 29/200 (14.5%; 95% CI: 9.9-20.1%) of maternity healthcare workers testing positive for IgG antibodies against SARS-CoV-2. Of those who had seroconverted, 10/29 (35.5%) were completely asymptomatic. Fever or cough were only present in 6/29 (20.7%) and (10/29 (34.5%) respectively. Anosmia was the most common symptom occurring in 15/29 (51.7%) seropositive participants and was the only symptom that was predictive of positive seroconversion (OR 18; 95% CI 6 – 55). 58.6% of those who were seropositive had not self-isolated at any point and continued to provide patient care in the hospital setting.This study was the largest study of baseline immune seroconversion in maternity healthcare workers conducted to date and reveals that 1 in 6 were seropositive, of whom 1 in 3 were asymptomatic. This has significant implications for the risk of occupational transmission of SARS-CoV-2 for both staff and patients in maternity and regular testing of staff, including asymptomatic staff should be considered to reduce transmission risk.

SARS-CoV-2 is a novel coronavirus causing a global pandemic of a severe respiratory illness known as COVID-19. To date, globally, over 30,000 people have died from this emerging disease. As clinicians and healthcare systems around the world are rapidly adapting to manage patients with COVID-19, limited data are emerging from different patient populations to support best-practice and improve outcomes. In this review, we present a summary of emerging data in the obstetric population and offer obstetric and anaesthetic clinicians around the world a set of evidence-driven, practice-based recommendations for the anaesthetic management of pregnant women with suspected or confirmed COVID-19.

ObjectiveTo identify, appraise, and synthesise the best available evidence on the efficacy of perioperative interventions to reduce postoperative pulmonary complications (PPCs) in adult patients undergoing non-cardiac surgery.DesignSystematic review and meta-analysis of randomised controlled trials.Data sourcesMedline, Embase, CINHAL, and CENTRAL from January 1990 to December 2017.Eligibility criteriaRandomised controlled trials investigating short term, protocolised medical interventions conducted before, during, or after non-cardiac surgery were included. Trials with clinical diagnostic criteria for PPC outcomes were included. Studies of surgical technique or physiological or biochemical outcomes were excluded.Data extraction and synthesisReviewers independently identified studies, extracted data, and assessed the quality of evidence. Meta-analyses were conducted to calculate risk ratios with 95% confidence intervals. Quality of evidence was summarised in accordance with GRADE methods. The primary outcome was the incidence of PPCs. Secondary outcomes were respiratory infection, atelectasis, length of hospital stay, and mortality. Trial sequential analysis was used to investigate the reliability and conclusiveness of available evidence. Adverse effects of interventions were not measured or compared.Results117 trials enrolled 21 940 participants, investigating 11 categories of intervention. 95 randomised controlled trials enrolling 18 062 participants were included in meta-analysis; 22 trials were excluded from meta-analysis because the interventions were not sufficiently similar to be pooled. No high quality evidence was found for interventions to reduce the primary outcome (incidence of PPCs). Seven interventions had low or moderate quality evidence with confidence intervals indicating a probable reduction in PPCs: enhanced recovery pathways (risk ratio 0.35, 95% confidence interval 0.21 to 0.58), prophylactic mucolytics (0.40, 0.23 to 0.67), postoperative continuous positive airway pressure ventilation (0.49, 0.24 to 0.99), lung protective intraoperative ventilation (0.52, 0.30 to 0.88), prophylactic respiratory physiotherapy (0.55, 0.32 to 0.93), epidural analgesia (0.77, 0.65 to 0.92), and goal directed haemodynamic therapy (0.87, 0.77 to 0.98). Moderate quality evidence showed no benefit for incentive spirometry in preventing PPCs. Trial sequential analysis adjustment confidently supported a relative risk reduction of 25% in PPCs for prophylactic respiratory physiotherapy, epidural analgesia, enhanced recovery pathways, and goal directed haemodynamic therapies. Insufficient data were available to support or refute equivalent relative risk reductions for other interventions.ConclusionsPredominantly low quality evidence favours multiple perioperative PPC reduction strategies. Clinicians may choose to reassess their perioperative care pathways, but the results indicate that new trials with a low risk of bias are needed to obtain conclusive evidence of efficacy for many of these interventions.Study registrationProspero CRD42016035662.

Levobupivacaine is a long-acting amide local anaesthetic used in analgesia and anaesthesia. Like other local anaesthetic drugs, levobupivacaine exhibits effects on motor and sensory nerves by inhibiting the opening of voltage-gated sodium channels, and hence propagation of neuronal action potentials. Levobupivacaine is the S(-) stereoisomer of dextrobupivacaine, although both are used commercially in the racemic form bupivacaine. A favourable safety and drug effect profile for levobupivacaine has led to widespread use. Levobupivacaine is generally well tolerated but dose adjustment is important in populations such as paediatrics and the elderly. The pharmacokinetic properties of levobupivacaine are similar to that of bupivacaine; both extensively metabolised in the liver, and excreted in the urine and faeces. In vitro, animal model and human studies confirm a lower risk of cardiac and central nervous system toxicity with levobupivacaine compared with bupivacaine. Clinical trials of relative potency are impaired by the variability in chosen endpoints for sensory and motor function blockade, but clinically significant differences in potency are minor, with most clinical trials showing similar duration and quality of anaesthesia between levo- and racemic bupivacaine. In practice, levobupivacaine is most commonly used in regional anaesthesia, neuraxial anaesthesia and local infiltration analgesia. This review includes an appraisal of evidence from clinical trials of the pharmacokinetic and pharmacodynamic properties of levobupivacaine.

Contains fulltext : 229026.pdf (Publisher’s version ) (Closed access) Personalised risk assessment of the likelihood of pulmonary aspiration is recommended for pregnant women undergoing general anaesthesia and gastric point-of-care ultrasound (PoCUS) may help to achieve this. Traditionally, risk assessment is based upon adherence to fasting times, but gastric emptying may vary during pregnancy and surgery often needs to be expedited. We systematically reviewed the evidence for gastric PoCUS up to August 2018 in pregnant and postpartum women to determine whether it can identify and quantify stomach contents, provide aspiration risk assessment via qualitative or quantitative means, and determine how gastric emptying is affected by pregnancy. Twenty-two articles comprising 1050 participants were included and studies were classified by qualitative or quantitative findings. The evidence suggests that gastric PoCUS is a reliable and feasible method of imaging the stomach in pregnancy in clinical practice. Qualitative assessment via the Perlas grading system can provide rapid assessment of gastric volume states. If fluid is visible, identification of patients at high risk of pulmonary aspiration requires measurement of antral cross-sectional area. Cut-off values of 608mm(2) and 960mm(2) are recommended in the semi-recumbent and right lateral semi-recumbent positions, respectively. Validated methods to quantify stomach volumes are available, however their usefulness is currently restricted to research. Gastric PoCUS also provides evidence that gastric emptying of ingested food is delayed by term pregnancy, labour and during the early postpartum period. However, the passage of fluids through the stomach appears unaffected throughout the peripartum period.

This chapter is based on the current core curriculum of the Royal College of Obstetricians and Gynaecologists training programme. It covers the relevant anaesthesia knowledge criteria in the management of labour and delivery. The chapter provides succinct and important pieces of information on the following: (1) types and methods of action of analgesia and sedation including narcotics, hypnotics, and non-steroidal anti-inflammatory drugs and their indications and contraindications; (2) types and methods of action of regional anaesthesia including epidural, spinal, and pudendal nerve block and their indications and contraindications; (3) complications of anaesthesia and analgesia including cardiac arrest, respiratory arrest, aspiration, and drug reactions; (4) anaesthesia agents—induction, inhalational, and prophylactic measures; and (5) advice on pain relief.

Vertebral canal haematoma following epidural anaesthesia is a rare but potentially devastating occurence, which can lead to permanent neurological damage. Early clinical identification and diagnosis using MRI imaging with surgical decompression of the haematoma can lead to full recovery (Kebaish 2004). However surgical patients often have metal clips or staples, which are left inside the body, some of which are not MRI compatible. Currently there is no process to document which surgical clips have been used and their MRI compatibility in an accessible format. This can lead to a delay in performing MRI imaging. We propose a clinical pathway to expedite diagnosis of vertebral canal haematoma to incorporate a system to allow rapid identification of MRI compatibility of surgical clips used during surgery.

Background Clinical indicators are powerful tools to quantify the safety and quality of patient care. Their validity is often unclear and definitions extremely heterogeneous. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid clinical outcome indicators for use in perioperative clinical trials. Methods We identified clinical indicators via a systematic review of the anaesthesia and perioperative medicine literature (PubMed/OVID, EMBASE, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 54 clinician–researchers worldwide. Indicators were first shortlisted and the most suitable definitions for evaluation of quality and safety interventions determined. Indicators were then assessed for validity, reliability, feasibility, and clarity. Results We identified 167 clinical outcome indicators. Participation in the three Delphi rounds was 100% (n=13), 68% (n=54), and 85% (n= 6), respectively. A final list of eight outcome indicators was generated: surgical site infection at 30 days, stroke within 30 days of surgery, death within 30 days of coronary artery bypass grafting, death within 30 days of surgery, admission to the intensive care unit within 14 days of surgery, readmission to hospital within 30 days of surgery, and length of hospital stay (with or without in-hospital mortality). They were rated by the majority of experts as valid, reliable, easy to use, and clearly defined. Conclusions These clinical indicators can be confidently used as endpoints in clinical trials measuring quality, safety, and improvement in perioperative care. Registration PROSPERO 2016 CRD42016042102 (http://www.crd.york.ac.uk/PROSPERO/display_record.php? ID=CRD42016042102).

IntroductionThe benefits and risk of intravenous iron have been documented in previous systematic reviews and continue to be the subject of randomised controlled trials (RCTs). An ongoing issue that continues to be raised is the relationship between administering iron and developing infection. This is supported by biological plausibility from animal models. We propose an update of a previously published systematic review and meta-analysis with the primary focus being infection.Methods and analysisWe will include RCTs and non-randomised studies (NRS) in this review update. We will search the relevant electronic databases. Two reviewers will independently extract data. Risk of bias for RCTs and NRS will be assessed using the relevant tools recommended by The Cochrane Collaboration. Data extracted from RCTs and NRS will be analysed and reported separately. Pooled data from RCTs will be analysed using a random effects model. We will also conduct subgroup analyses to identify any patient populations that may be at increased risk of developing infection. We will provide a narrative synthesis on the definitions, sources and responsible pathogens for infection in the included studies. Overall quality of evidence on the safety outcomes of mortality and infection will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach.Ethics and disseminationThis systematic review will only investigate published studies and therefore ethical approval is not required. The results will be broadly distributed through conference presentations and peer-reviewed publications.Trial registration numberPROSPERO (CRD42018096023).

IntroductionClinical indicators are used to measure and quantify the safety and quality of patient care. They are also often used as endpoints in clinical trials. Definitions of clinical indicators in common use are extremely heterogeneous, limiting their applicability. As part of the international Standardised Endpoints in Perioperative Medicine initiative, this study will identify clinical indicators by systematically reviewing the anaesthesia and perioperative medicine literature, and will provide consensus, clinically useful definitions for those indicators using a Delphi process.Methods and analysisAn electronic database search will be conducted of Medline (PubMed/OVID), EMBASE and the Cochrane Library in order to meet this review’s objectives that are: (1) To identify clinical indicators and their definitions used in randomised controlled trials that assess patient-related quality and safety interventions in perioperative medicine; (2) To select a shortlist of recommended indicators and definitions that are the most suitable for evaluation of quality and safety interventions following an expert-based consensus-gaining process (Delphi method) and (3) To provide a classification scale for each indicator related to its clarity of definition, validity (strength), reliability, feasibility (ease of use) and frequency of use. This systematic review protocol is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidance.Ethics and disseminationEthical approval is not required for this systematic review and Delphi process. The results of this study will be disseminated to the anaesthesia and perioperative medicine clinical and academic community through national and international presentations and through publication in a peer reviewed journal.PROSPERO registration numberCRD42016042102.

Background: Delirium is a common post-operative complication, particularly in older adults undergoing major or emergency procedures. It is associated with increased length of intensive care and hospital stay, post-operative mortality and subsequent dementia risk. Current methods of predicting delirium incidence, duration and severity have limitations. Investigation of blood and cerebrospinal fluid (CSF) biomarkers linked to delirium may improve understanding of the underlying pathophysiology, particularly with regard to the extent this is shared or distinct with underlying dementia. Together, these have the potential for development of better risk stratification tools and perioperative interventions. Methods: 200 patients over the age of 70 scheduled for surgery with routine spinal anaesthetic will be recruited from UK hospitals. Their cognitive and functional baseline status will be assessed pre-operatively by telephone. Time-matched CSF and blood samples will be taken at the time of surgery and analysed for known biomarkers of neurodegeneration and neuroinflammation. Patients will be assessed daily for delirium until hospital discharge and will have regular cognitive follow-up for two years. Primary outcomes will be change in modified Telephone Interview for Cognitive Status (TICS-m) score at 12 months and rate of change of TICS-m score. Delirium severity, duration and biomarker levels will be treated as exposures in a random effects linear regression models. PRIMED Risk has received regulatory approvals from Health Research Authority and London – South East Research Ethics Committee. Discussion: The main anticipated output from this study will be the quantification of biomarkers of acute and chronic contributors to cognitive impairment after surgery. In addition, we aim to develop better risk prediction models for adverse cognitive outcomes.

OBJECTIVE: To perform a systematic review of randomized trials comparing oral versus intravenous iron therapy to treat postpartum anemia. DATA SOURCES: Data sources were: PubMed (1972–2017); Cochrane Central Register of Controlled Trials, CENTRAL (1972–2017); CINAHL (1972–2017); Web of Science; Excerpta Medica Database, and EMBASE (1972–2017). STUDY ELIGIBILITY CRITERIA: We included randomized trials comparing oral versus intravenous iron monotherapy to treat postpartum anemia (classified as a hemoglobin

Background: The Standardising Endpoints for Perioperative Medicine group was established to derive an appropriate set of endpoints for use in clinical trials related to anaesthesia and perioperative medicine. Anaesthetic or analgesic technique during cancer surgery with curative intent may influence the risk of recurrence or metastasis. However, given the current equipoise in the existing literature, prospective, randomised, controlled trials are necessary to test this hypothesis. As such, a cancer subgroup was formed to derive endpoints related to research in onco-anaesthesia based on a current evidence base, international consensus and expert guidance.Methods: We undertook a systematic review to identify measures of oncological outcome used in the oncological, surgical, and wider literature. A multiround Delphi consensus process that included up to 89 clinician–researchers was then used to refine a recommended list of endpoints.Results: We identified 90 studies in a literature search, which were the basis for a preliminary list of nine outcome measures and their definitions. A further two were added during the Delphi process. Response rates for Delphi rounds one, two, and three were 88% (n=9), 82% (n=73), and 100% (n=10), respectively. A final list of 10 defined endpoints was refined and developed, of which six secured approval by ≥70% of the group: cancer health related quality of life, days alive and out of hospital at 90 days, time to tumour progression, disease-free survival, cancer-specific survival, and overall survival (and 5-yr overall survival).Conclusion: Standardised endpoints in clinical outcomes studies will support benchmarking and pooling (meta-analysis) of trials. It is therefore recommended that one or more of these consensus-derived endpoints should be considered for inclusion in clinical trials evaluating a causal effect of anaesthesia–analgesia technique on oncological outcomes.

Purpose of Review Cardiac output monitors can be assessed by a variety of techniques, but a common principle is quantifying agreement between a reference standard and new monitor. The current standard analysis technique is a Bland-Altman plot. The Bland-Altman plot evaluates bias between mean differences of cardiac output, from which an agreement interval is derived. These limits are, however, statistical limits of agreement and the clinical acceptability will depend upon context and application. This article provides suggestions for understanding and presenting the results of cardiac output validation, using standard metrology alongside proposals for criteria used to accept new techniques. Recent Findings Confusion about the appropriate way to report “precision” in method comparison studies stem from a lack of clarity on how single or repeated measurements should be interpreted. During serial measurements of cardiac output the true value changes, thus measurement should be considered as serial rather than repeated. Method agreement based upon precision achieved by cardiac output monitors needs to consider each method’s general variability around true values obtained and this data should be generated and presented as part of each study design. Summary Studies should report serial measurements from two techniques for cardiac output monitoring. Results of similar techniques from other studies may not always be transferred and compared. Bias and intervals of agreement should be presented as Bland-Altman plots with dynamic cardiac output trends in polar plots. Percentage error should be calculated to allow appropriate comparison of techniques for study populations with different expected cardiac output values.

This article outlines the growing demand for surgical services globally, both in developing and developed countries. The implications of this increasing demand are explored, with particular attention focused on the enduring burden of perioperative complications. The role of critical care in ensuring the safe delivery of surgical services is also examined. Solutions to the ‘surgical epidemic’ are proposed including the role of perioperative medicine in reconfiguring services to provide safe surgical care.

Background Little is known about the economic impact of emergency laparotomy (EL) surgery in healthcare systems around the world. The aim of this systematic review is to describe the primary resource utilisation, healthcare economic and societal costs of EL in adults in different countries. Methods MEDLINE, EMBASE, ISI Web of Knowledge, Cochrane Central Register Controlled Trials, Cochrane Database of Systematic Reviews and CINAHL were searched for full and partial economic analyses of EL published between 1 January 1991 and 31 December 2015. Quality of studies was assessed using the Consensus on Health Economic Criteria (CHEC) checklist. Results Sixteen studies were included from a range of countries. One study was a full economic analysis. Fifteen studies were partial economic evaluations. These studies revealed that emergency abdominal surgery is expensive compared to similar elective surgery when comparing primary resource utilisation costs, with an important societal impact. Most contemporaneous studies indicate that in-hospital costs for EL are in excess of US$10,000 per patient episode, rising substantially when societal costs are considered. Discussion EL is a high-risk and costly procedure with a disproportionate financial burden for healthcare providers, relative to national funding provisions and wider societal cost impact. There is substantial heterogeneity in the methodologies and quality of published economic evaluations of EL; therefore, the true economic costs of EL are yet to be fully defined. Future research should focus on developing strategies to embed health economic evaluations within national programmes aiming to improve EL care, including developing the required measures and infrastructure. Conclusions Emergency laparotomy is expensive, with a significant cost burden to healthcare and systems and society worldwide. Novel strategies for reducing this econmic burden should urgently be explored if greater access to this type of surgery is to be pursued as a global health target. Trial registration PROSPERO registration no. 42015027210 .

Background Perioperative fluid strategies influence clinical outcomes following major surgery. Many intravenous fluid preparations are based on simple solutions, such as normal saline, that feature an electrolyte composition that differs from that of physiological plasma. Buffered fluids have a theoretical advantage of containing a substrate that acts to maintain the body’s acid-base status - typically a bicarbonate or a bicarbonate precursor such as maleate, gluconate, lactate, or acetate. Buffered fluids also provide additional electrolytes, including potassium, magnesium, and calcium, more closely matching the electrolyte balance of plasma. The putative benefits of buffered fluids have been compared with those of non-buffered fluids in the context of clinical studies conducted during the perioperative period. This review was published in 2012, and was updated in 2017. Objectives To review effects of perioperative intravenous administration of buffered versus non-buffered fluids for plasma volume expansion or maintenance, or both, on clinical outcomes in adults undergoing all types of surgery. Search methods We electronically searched the Clinicaltrials.gov major trials registry, the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 6) in the Cochrane Library, MEDLINE (1966 to June 2016), Embase (1980 to June 2016), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to June 2016). We handsearched conference abstracts and, when possible, contacted leaders in the field. We reran the search in May 2017. We added one potential new study of interest to the list of ‘Studies awaiting classification' and will incorporate this trial into formal review findings when we prepare the review update. Selection criteria Only randomized controlled trials that compared buffered versus non-buffered intravenous fluids for surgical patients were eligible for inclusion. We excluded other forms of comparison such as crystalloids versus colloids and colloids versus different colloids. Data collection and analysis Two review authors screened references for eligibility, extracted data, and assessed risks of bias. We resolved disagreements by discussion and consensus, in collaboration with a third review author. We contacted trial authors to request additional information when appropriate. We presented pooled estimates for dichotomous outcomes as odds ratios (ORs) and for continuous outcomes as mean differences (MDs), with 95% confidence intervals (CIs). We analysed data via Review Manager 5.3 using fixed-effect models, and when heterogeneity was high (I² > 40%), we used random-effects models. Main results This review includes, in total, 19 publications of 18 randomized controlled trials with a total of 1096 participants. We incorporated five of those 19 studies (330 participants) after the June 2016 update. Outcome measures in the included studies were thematically similar, covering perioperative electrolyte status, renal function, and acid-base status; however, we found significant clinical and statistical heterogeneity among the included studies. We identified variable protocols for fluid administration and total volumes of fluid administered to patients intraoperatively. Trial authors variably reported outcome data at disparate time points and with heterogeneous patient groups. Consequently, many outcome measures are reported in small group sizes, reducing overall confidence in effect size, despite relatively low inherent bias in the included studies. Several studies reported orphan outcome measures. We did not include in the results of this review one large, ongoing study of saline versus Ringer's solution. We found insufficient evidence on effects of fluid therapies on mortality and postoperative organ dysfunction (defined as renal insufficiency leading to renal replacement therapy); confidence intervals were wide and included both clinically relevant benefit and harm: mortality (Peto OR 1.85, 95% CI 0.37 to 9.33; I² = 0%; 3 trials, 6 deaths, 276 participants; low-quality evidence); renal insufficiency (OR 0.82, 95% CI 0.34 to 1.98; I² = 0%; 4 trials, 22 events, 276 participants; low-quality evidence). We noted several metabolic differences, including a difference in postoperative pH measured at end of surgery of 0.05 units - lower in the non-buffered fluid group (12 studies with a total of 720 participants; 95% CI 0.04 to 0.07; I² = 61%). However, this difference was not maintained on postoperative day one. We rated the quality of evidence for this outcome as moderate. We observed a higher postoperative serum chloride level immediately after operation, with use of non-buffered fluids reported in 10 studies with a total of 530 participants (MD 6.77 mmol/L, 95% CI 3.38 to 10.17), and this difference persisted until day one postoperatively (five studies with a total of 258 participants; MD 8.48 mmol/L, 95% CI 1.08 to 15.88). We rated the quality of evidence for this outcome as moderate. Authors' conclusions Current evidence is insufficient to show effects of perioperative administration of buffered versus non-buffered crystalloid fluids on mortality and organ system function in adult patients following surgery. Benefits of buffered fluid were measurable in biochemical terms, particularly a significant reduction in postoperative hyperchloraemia and metabolic acidosis. Small effect sizes for biochemical outcomes and lack of correlated clinical follow-up data mean that robust conclusions on major morbidity and mortality associated with buffered versus non-buffered perioperative fluid choices are still lacking. Larger studies are needed to assess these relevant clinical outcomes.

Background: There is a need for robust, clearly defined, patient-relevant outcome measures for use in randomised trials in perioperative medicine. Our objective was to establish standard outcome measures for postoperative pulmonary complications research.Methods: A systematic literature search was conducted using MEDLINE, Web of Science, SciELO, and the Korean Journal Database. Definitions were extracted from included manuscripts. We then conducted a three-stage Delphi consensus process to select the optimal outcome measures in terms of methodological quality and overall suitability for perioperative trials.Results: From 2358 records, the full texts of 81 manuscripts were retrieved, of which 45 met the inclusion criteria. We identified three main categories of outcome measure specific to perioperative pulmonary outcomes: (i) composite outcome measures of multiple pulmonary outcomes (27 definitions); (ii) pneumonia (12 definitions); and (iii) respiratory failure (six definitions). These were rated by the group according to suitability for routine use. The majority of definitions were given a low score, and many were imprecise, difficult to apply consistently, or both, in large patient populations. A small number of highly rated definitions were identified as appropriate for widespread use. The group then recommended four outcome measures for future use, including one new definition.Conclusions: A large number of postoperative pulmonary outcome measures have been used, but most are poorly defined. Our four recommended outcome measures include a new definition of postoperative pulmonary complications, incorporating an assessment of severity. These definitions will meet the needs of most clinical effectiveness trials of treatments to improve postoperative pulmonary outcomes.

This randomised controlled trial investigated the efficacy of Epi-Fix(™) , LockIt Plus(®) and Tegaderm(™) as fixation devices for intrapartum epidural catheters. One hundred and sixty-five women requesting intrapartum epidural analgesia were randomised to receive different fixation devices to secure their epidural catheter. The amount of epidural catheter migration (measured to the nearest 0.5 cm) was analysed for three devices: Epi-Fix (n = 55); LockIt Plus (n = 54); and Tegaderm dressing (n = 51). Median (IQR [range]) catheter migration for Epi-Fix was 1.0 cm (0.0-2.0 [-2.0 to 9.5]), vs 0.0 cm (0.0-0.5 [-1.0 to 5.5]) for LockIt Plus and 0.5 cm (0.0-1.8 [-1.5 to 8.0]) for Tegaderm (p = 0.003). Thirty-eight (69.1%) epidural catheters secured with Epi-Fix migrated < 2.0 cm, compared with 49 (90.7%) with LockIt Plus and 40 (78.4%) with Tegaderm. Sixteen epidural catheters required resiting due to failure of analgesia of which 12 (75.0%) occurred in patients with epidural catheters that had migrated ≥ 2.0 cm. This study shows that intrapartum epidural catheters secured with the LockIt Plus device exhibit less catheter migration compared with fixation with Epi-Fix and Tegaderm.

Background: Intraoperative haemodynamic monitoring is carried out in high-risk surgical patients, often using invasive methods, including pulmonary artery catheterisation. Early goal-directed therapy in high-risk surgical patients reduces tissue hypoxia, organ failure and improves outcomes. Significant maternal morbidity arises as a result of perioperative haemorrhage. At present, heart rate and brachial blood pressure are used as proxy markers to aid in fluid resuscitation, however, we know that these exhibit minimal change during early stages of shock, and are poor indicators of the adequacy of therapeutic intervention.Objective: The aim of this study was to compare the cardiac output trends observed during C-section for morbidly adherent placenta, using NICOM® and LiDCOrapid®.Methods: This is an ongoing, prospective observational study in women undergoing planned high-risk surgery for morbidly adherent placenta in a tertiary centre. Cardiac output estimations were collected at 2 min intervals, ...