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5. A comparison of the McGrath videolaryngoscope with direct laryngoscopy for rapid sequence intubation in the operating theatre: a multicentre randomised controlled trial.

Author

Kriege, M., Lang, P., Lang, C., Schmidtmann, I., Kunitz, O., Roth, M., Strate, M., Schmutz, A., Vits, E., Balogh, O., and Jänig, C.

Subjects
LARYNGOSCOPES, LARYNGOSCOPY, RANDOMIZED controlled trials, TRACHEA intubation, INTUBATION, SURGICAL emergencies
Abstract

Summary: Aspiration of gastric contents is a recognised complication during all phases of anaesthesia. The risk of this event becomes more likely with repeated attempts at tracheal intubation. There is a lack of clinical data on the effectiveness of videolaryngoscopy relative to direct laryngoscopy rapid sequence intubation in the operating theatre. We hypothesised that the use of a videolaryngoscope during rapid sequence intubation would be associated with a higher first pass tracheal intubation success rate than conventional direct laryngoscopy. In this multicentre randomised controlled trial, 1000 adult patients requiring tracheal intubation for elective, urgent or emergency surgery were allocated randomly to airway management using a McGrath™ MAC videolaryngoscope (Medtronic, Minneapolis, MN, USA) or direct laryngoscopy. Both techniques used a Macintosh blade. First‐pass tracheal intubation success was higher in patients allocated to the McGrath group (470/500, 94%) compared with those allocated to the direct laryngoscopy group (358/500, 71.6%), odds ratio (95%CI) 1.31 (1.23–1.39); p < 0.001. This advantage was observed in both trainees and consultants. Cormack and Lehane grade ≥ 3 view occurred less frequently in patients allocated to the McGrath group compared with those allocated to the direct laryngoscopy group (5/500, 1% vs. 94/500, 19%, respectively; p < 0.001). Tracheal intubation with a McGrath videolaryngoscope was associated with a lower rate of adverse events compared with direct laryngoscopy (13/500, 2.6% vs. 61/500, 12.2%, respectively; p < 0.001). These findings suggest that the McGrath videolaryngoscope is superior to a conventional direct laryngoscope for rapid sequence intubation in the operating theatre. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Recovery of right ventricular function after intermediate-risk pulmonary embolism: results from the multicentre Pulmonary Embolism International Trial (PEITHO)-2

Author

Mavromanoli, A.C., Barco, S., Ageno, W., Bouvaist, H., Brodmann, M., Cuccia, C., Couturaud, F., Dellas, C., Dimopoulos, K., Duerschmied, D., Empen, K., Faggiano, P., Ferrari, E., Galie, N., Galvani, M., Ghuysen, A., Giannakoulas, G., Huisman, M.V., Jimenez, D., Kozak, M., Lang, I.M., Meneveau, N., Munzel, T., Palazzini, M., Petris, A.O., Piovaccari, G., Salvi, A., Schellong, S., Schmidt, K.H., Verschuren, F., Schmidtmann, I., Toenges, G., Klok, F.A., Konstantinides, S.V., and PEITHO-2 Investigators

Subjects
Science & Technology, Cardiac & Cardiovascular Systems, Pulmonary embolism, WORKING GROUP, General Medicine, ASSOCIATION, GUIDELINES, EUROPEAN-SOCIETY, DYSFUNCTION, Echocardiography, Dysfunction, Cardiovascular System & Cardiology, MANAGEMENT, HEART, Right ventricle, Intermediate-risk, Cardiology and Cardiovascular Medicine, FOLLOW-UP, Life Sciences & Biomedicine, CARDIOLOGY
Abstract

Background Right ventricular (RV) function plays a critical role in the pathophysiology and acute prognosis of pulmonary embolism (PE). We analyzed the temporal changes of RV function in the cohort of a prospective multicentre study investigating if an early switch to oral anticoagulation in patients with intermediate-risk PE is effective and safe. Methods Echocardiographic and laboratory examinations were performed at baseline (PE diagnosis), 6 days and 6 months. Echocardiographic parameters were classified into categories representing RV size, RV free wall/tricuspid annulus motion, RV pressure overload and right atrial (RA)/central venous pressure. Results RV dysfunction based on any abnormal echocardiographic parameter was present in 84% of patients at baseline. RV dilatation was the most frequently abnormal finding (40.6%), followed by increased RA/central venous pressure (34.6%), RV pressure overload (32.1%), and reduced RV free wall/tricuspid annulus motion (20.9%). As early as day 6, RV size remained normal or improved in 260 patients (64.7%), RV free wall/tricuspid annulus motion in 301 (74.9%), RV pressure overload in 297 (73.9%), and RA/central venous pressure in 254 (63.2%). At day 180, the frequencies slightly increased. The median NT-proBNP level decreased from 1448 pg/ml at baseline to 256.5 on day 6 and 127 on day 180. Conclusion In the majority of patients with acute intermediate-risk PE switched early to a direct oral anticoagulant, echocardiographic parameters of RV function normalised within 6 days and remained normal throughout the first 6 months. Almost one in four patients, however, continued to have evidence of RV dysfunction over the long term. Graphical Abstract

Published
2022

18. A multicentre randomised controlled trial of the McGrath™ Mac videolaryngoscope versus conventional laryngoscopy.

Author

Kriege, M., Noppens, R. R., Turkstra, T., Payne, S., Kunitz, O., Tzanova, I., Schmidtmann, I., Alflen, C., Griemert, E. V., Heid, F., Pirlich, N., Wittenmeier, E., Flier, S., Chui, J., Piepho, T., and Venker, B.

Subjects
LARYNGOSCOPES, LARYNGOSCOPY, RANDOMIZED controlled trials, TRACHEA intubation, ELECTIVE surgery
Abstract

Summary: Before completion of this study, there was insufficient evidence demonstrating the superiority of videolaryngoscopy compared with direct laryngoscopy for elective tracheal intubation. We hypothesised that using videolaryngoscopy for routine tracheal intubation would result in higher first‐pass tracheal intubation success compared with direct laryngoscopy. In this multicentre randomised trial, 2092 adult patients without predicted difficult airway requiring tracheal intubation for elective surgery were allocated randomly to either videolaryngoscopy with a Macintosh blade (McGrath™) or direct laryngoscopy. First‐pass tracheal intubation success was higher with the McGrath (987/1053, 94%), compared with direct laryngoscopy (848/1039, 82%); absolute risk reduction (95%CI) was 12.1% (10.9–13.6%). This resulted in a relative risk (95%CI) of unsuccessful tracheal intubation at first attempt of 0.34 (0.26–0.45; p < 0.001) for McGrath compared with direct laryngoscopy. Cormack and Lehane grade ≥ 3 was observed more frequently with direct laryngoscopy (84/1039, 8%) compared with McGrath (8/1053, 0.7%; p < 0.001) No significant difference in tracheal intubation‐associated adverse events was observed between groups. This study demonstrates that using McGrath videolaryngoscopy compared with direct laryngoscopy improves first‐pass tracheal intubation success in patients having elective surgery. Practitioners may consider using this device as first choice for tracheal intubation. [ABSTRACT FROM AUTHOR]

Published
2023
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24. A systematic review and evaluation of methods for group variable selection

Author

Buch, G, Schulz, A, Schmidtmann, I, Strauch, K, and Wild, P

Subjects
ddc: 610, systematic review, Medicine and health, simulation study, group variable selection
Abstract

Introduction: Many datasets have a natural group structure due to high correlations or contextual similarities of variables, like in proteomics. Group variable selection methods are able to account for such structure in the selection process to identify variables that are related to each other and share [for full text, please go to the a.m. URL]

Published
2021
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31. Cooperating working groups of GMDS, IBS-DR, DGEpi & DGSMP: a platform for training and scientific exchange on statistics and methods in medicine, clinical research and epidemiology

Author

Hardt, J, Schmidtmann, I, Hoffmann, VS, Krahn, U, Siebert, U, Rubarth, K, Behr, S, Friedrich, S, Jahn, A, Rübsamen, N, Lotz, A, Stark, M, Mildenberger, P, Ozga, AK, Brinks, R, and Schmidt, CO

Subjects
psychometrics, biometry, methodology, 610 Medical sciences, Medicine, methods, continuous quality management, study design, ddc: 610, statistics, surveys and questionnaires, data accuracy, data quality, clinical studies, causal inference
Abstract

Introduction: The 4 working groups “Statistical Methods in Medicine” (IBS-DR), “Statistical Methods in Epidemiology” (IBS-DR, DGEpi, DAGStat, DGSMP), “Statistical Methods in Clinical Research” (GMDS) and “Epidemiologic Methods” (GMDS, DGEpi, DGSMP)[for full text, please go to the a.m. URL], 65th Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Meeting of the Central European Network (CEN: German Region, Austro-Swiss Region and Polish Region) of the International Biometric Society (IBS)

Published
2021
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32. Kennen wir den Bedarf der Katarakt- und Glaukomchirurgie? Herausforderungen und Grenzen der Versorgungsforschung

Author

Nickels, Stefan, Schuster, A.K., Pfeiffer, N., Schmidtmann, I., Wild, P.S., Münzel, T., Beutel, M.E., Lackner, K.J., and Voßmerbäumer, U.

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Fragestellung: Die Katarakt-Operation gilt als die häufigste Operation in Deutschland. Zahlen hierzu basieren bisher auf Umfragen oder Verkaufszahlen von Intraokularlinsen. Wir berichten nun die Häufigkeit von Kataraktoperationen über ein Fünfjahresintervall bei Personen im Alter[zum vollständigen Text gelangen Sie über die oben angegebene URL], 34. Kongress der Deutschsprachigen Gesellschaft für Intraokularlinsen-Implantation, interventionelle und refraktive Chirurgie

Published
2020

33. Häufigkeit der Katarakt-Operation und deren Einfluss auf die visuelle Funktion - Ergebnisse der Gutenberg-Gesundheitsstudie (GHS)

Author

Schuster, Alexander K., Nickels, S., Pfeiffer, N., Schmidtmann, I., Wild, P.S., Münzel, T., Beutel, M.E., Lackner, K.J., and Voßmerbäumer, U.

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Fragestellung: Die Katarakt-Operation gilt als die häufigste Operation in Deutschland. Zahlen hierzu basieren bisher auf Umfragen oder Verkaufszahlen von Intraokularlinsen. Wir berichten nun die Häufigkeit von Kataraktoperationen über ein Fünfjahresintervall bei Personen im Alter[zum vollständigen Text gelangen Sie über die oben angegebene URL], 34. Kongress der Deutschsprachigen Gesellschaft für Intraokularlinsen-Implantation, interventionelle und refraktive Chirurgie

Published
2020

34. Niedriges Geburtsgewicht ist assoziiert mit der altersbedingten Makuladegeneration im Erwachsenenalter – Ergebnisse der Gutenberg-Gesundheitsstudie

Author

Fieß, A, Elbaz, H, Korb, CA, Nickels, S, Schulz, A, Münzel, T, Wild, PS, Beutel, ME, Schmidtmann, I, Lackner, KJ, Peto, T, Pfeiffer, N, and Schuster, AK

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Ziel: Diese Studie analysiert, ob ein niedriges Geburtsgewicht (GG) mit der Prävalenz und Inzidenz der altersbedingten Makuladeneration (AMD) im Erwachsenenalter zusammenhängt. Methoden: Die Gutenberg-Gesundheitsstudie (GHS) ist eine bevölkerungsbezogene, beobachtende Kohortenstudie[zum vollständigen Text gelangen Sie über die oben angegebene URL], 92. Versammlung des Vereins Rhein-Mainischer Augenärzte

Published
2020
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35. Palliative care in undergraduate medical education - consolidation of the learning contents of palliative care in the final academic year

Author

Gerlach, C, Mai, SS, Schmidtmann, I, Weber, M, Gerlach, C, Mai, SS, Schmidtmann, I, and Weber, M

Abstract

Background: Demographic change and the medical imperative to accompany patients at all times and also in the case of illness leading to death require good basic knowledge of palliative care in large parts of the medical profession. Palliative care has been introduced into undergraduate medical education as a compulsory subject: "interdisciplinary subject 13 palliative care" (Q13). While course concepts for Q13 have already been positively evaluated, assessment of the consolidation and practical relevance of the knowledge taught is lacking.Methods: Assessment of the consolidation of the learning content from Q13 after the practical year (the "practical year" is the sixth and final year of undergraduate medical education in Germany) by means of a survey with a proven questionnaire and integrated qualitative free-text analysis of a cohort of medical students (n=176) who had already participated in an evaluation before and after Q13.Results: The response rate was 96% after Q13 and 45% after the practical year (PY). Teaching was predominantly perceived as more helpful than the PY (p<0.001). Compared to the status after Q13, students rated themselves as less competent after the PY in all areas surveyed, including drug-based pain therapy (p=0.0386). The certainty in informing patients about the incurability of the disease also decreased significantly after the PY (p=0.0117), although the preparation in Q13 was positively highlighted.Conclusion: The knowledge acquired in Q13 could not be anchored in the PY. On the contrary, after initial practical experiences, the students found it challenging to conduct conversations in cases of serious illness and to deal with their own uncertainty in the care of seriously ill patients. Structural factors regarding palliative care in the PY, as well as intrinsic motives of students, such as prior knowledge or motivation to learn, should be analyzed to identify ways to close the gap between theoretical and practical training in general pal, Hintergrund: Der demographische Wandel und der ärztliche Anspruch Patientinnen und Patienten stets und auch bei zum Tode führenden Erkrankungen zu begleiten, erfordern gute palliativmedizinische Basiskenntnisse in weiten Teilen der Ärzteschaft. Mit Wirkung zum Sommersemester 2013 ist Palliativmedizin als "Querschnittbereich 13 (Q13)" als Pflichtfach in das Medizinstudium eingeführt worden. Während Kurskonzepte zum Q13 bereits positiv evaluiert wurden, fehlt die Beurteilung der Konsolidierung und Praxisrelevanz der vermittelten Kenntnisse. Methode: Beurteilung der Konsolidierung der Lerninhalte aus Q13 nach dem Praktischen Jahr (PJ) mittels Befragung mit einem erprobten Fragebogen und integrierter qualitativer Freitextanalyse einer Kohorte von Medizinstudierenden (n=176), die bereits an einer Evaluation vor und nach Q13 teilgenommen hatten. Ergebnis: Die Rücklaufquote betrug 96% nach Q13 und 45% nach dem PJ. Der Unterricht wurde überwiegend als hilfreicher empfunden als das PJ (p<0.001). Im Vergleich zum Stand nach Q13 schätzten sich die Studierenden nach dem PJ in allen abgefragten Bereichen als weniger kompetent ein, einschließlich der medikamentösen Schmerztherapie (p=0.0386). Auch die Sicherheit in der Aufklärung von Patienten über die Unheilbarkeit der Erkrankung nahm nach dem PJ signifikant ab (p=0.0117), obgleich die Vorbereitung durch Q13 positiv hervorgehoben wurde.Schlussfolgerung: Die im Q13 erworbenen Kenntnisse konnten im PJ nicht verankert werden. Im Gegenteil wurden die Gesprächsführung bei schwerer Erkrankung und der Umgang mit eigener Unsicherheit in der Behandlung von Schwerkranken von den Studierenden nach erster Praxiserfahrung als herausfordernd erachtet. Strukturelle Faktoren zu Palliativmedizin im PJ sowie intrinsische Motive der Studierenden, wie z.B. Vorwissen oder Lernmotivation, sollten analysiert werden, um Möglichkeiten zu erkennen, wie die Lücke zwischen theoretischer und praktischer Ausbildung in der allgemeinen Palliativversorgung gesc

Published
2021

48. Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical trial

Author

Schmidtmann, I. (Irene), Ageno, W. (Walter), Bauersachs, R.M. (Rupert M.), Becattini, C. (Cecilia), Bernardi, E. (Enrico), Beyer-Westendorf, J. (Jan), Bonacchini, L. (Luca), Brachmann, J. (Johannes), Christ, M. (Michael), Czihal, M. (Michael), Duerschmied, D. (Daniel), Empen, K. (Klaus), Espinola-Klein, C. (Christine), Ficker, J.H. (Joachim H.), Fonseca, C. (Candida), Genth-Zotz, S. (Sabine), Jiménez, D. (David), Harjola, V.P. (Veli-Pekka), Held, M. (Matthias), Iogna-Prat, L. (Lorenzo), Lange, T.J. (Tobias J.), Manolis, A. (Athanasios), Meyer, A. (Andreas), Mustonen, P. (Pirjo), Rauch-Kroehnert, U. (Ursula), Ruiz-Artacho, P. (Pedro), Schellong, S. (Sebastian), Schwaiblmair, M. (Martin), Stahrenberg, R. (Raoul), Westerweel, P.E. (Peter), Wild, P.S. (Philipp S.), Konstantinides, S.V. (Stavros V.), and Lankeit, M. (Mareike)

Subjects
Rivaroxaban, Pulmonary embolism, Home treatment, Management trial, Right ventricular dysfunction, Risk stratification
Abstract

Aims To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. Methods and results We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for >_3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of a = 0.004 (

Published
2020

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