- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07615582
Clinical Performance and Multitasking in Anesthesia : a Simulation-based Study (FOCUS)
Cognitive failure under multitasking conditions has been demonstrated in various settings, including healthcare. However, in anesthesiology, the impact of multitasking on clinical performance in a simulated environment has not yet been fully characterized.
The objective of our study is to evaluate the impact of multitasking on anesthesiologists' clinical performance in a simulated setting.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This study is a prospective, single-center, non-interventional, randomized crossover study, within-control subject.
The study was classified as non-interventional by the institutional research committee, as the intervention consists of simulation training and the study population is healthcare practitioners.
The study participants are anesthesiologists: attending physicians and residents. Each participant will serve as their own control. The study will comprise two visits: one intervention visit consisting of a multitasking simulation session, and one control visit involving clinical questions administered under quiet conditions. The order of the visits will be randomized between participants using a crossover design in order to minimize potential learning bias.
The multitasking condition will consist of manual mask ventilation performed on a manikin while participants are simultaneously exposed to oral clinical questions administered in the form of Script Concordance Tests (SCTs). Participants will be instructed to ventilate the manikin at a tidal volume of 500 ml and a respiratory rate of 16 cycles/minute.
Clinical reasoning under quiet conditions will also consist of answering oral clinical questions in the SCT format.
The study will use a 44-item Script Concordance Test (SCT) distributed across 20 anesthesiology clinical vignettes. Vignettes are distributed as follows: 8 vignettes with 3 items, 8 vignettes with 2 items, and 4 vignettes with 1 item. The vignettes were adapted, without modification of their content, to be compatible with oral administration and the simulation scenario.
In addition, for each participant, the SCT clinical vignettes will be randomized between the "simulation vignettes" and the "control vignettes," with stratification according to the number of items per vignette. 5 vignettes will be allocated to intervention, and 15 to control. This approach will help limit the effect of differences in vignette difficulty that could otherwise bias the results. At the group level, all clinical vignettes will ultimately be assessed both in the simulation and in the control conditions.
Detailed information is available in the study protocol.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Jean-Noël Evain, MD, PhD
- Telefonní číslo: +33476766829
- E-mail: jnevain@chu-grenoble.fr
Studijní záloha kontaktů
- Jméno: Caroline Sanchez, PhD
- Telefonní číslo: 0476766829
- E-mail: csanchez5@chu-grenoble.fr
Studijní místa
-
-
-
Grenoble, Francie, 38700
- Centre d'Évaluation et de Simulation Alpes Recherche (CESAR)
-
Kontakt:
- Jean-Noël Evain, MD, PhD
- Telefonní číslo: 0476766829
- E-mail: jnevain@chu-grenoble.fr
-
Kontakt:
- Alexis Lesage, MD
- Telefonní číslo: 0476766829
- E-mail: ALesage@chu-grenoble.fr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Anesthesiology and intensive care resident or attending physician
- Written informed consent
Exclusion Criteria:
- None
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Concordance score with the expert panel on a Script Concordance Test (SCT)
Časové okno: At two time points: - During simulation session under multitasking conditions - During control visit under quiet conditions
|
Each item of the SCT is scored out of 1 point, and the sum of the points, converted to a 100-point scale, defines the percentage of concordance with the expert panel.
|
At two time points: - During simulation session under multitasking conditions - During control visit under quiet conditions
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Manual ventilation performance assessed by deviation from the instructed tidal volume per cycle (milliliters).
Časové okno: During simulation, comparison between manual ventilation interrupted by clinical questions versus manual ventilation alone
|
│Instructed tidal volume- Observed tidal volume│/ cycle (milliliters)
|
During simulation, comparison between manual ventilation interrupted by clinical questions versus manual ventilation alone
|
|
Manual ventilation performance assessed by deviation from the instructed respiratory rate (cycles/minutes).
Časové okno: During simulation, comparison between manual ventilation interrupted by clinical questions versus manual ventilation alone
|
│Instructed respiratory rate- Observed respiratory rate│
|
During simulation, comparison between manual ventilation interrupted by clinical questions versus manual ventilation alone
|
|
Cognitive load assessed by the NASA-TLX index (score out of 100)
Časové okno: A two time points: - Evaluating cognitive load of manual ventilation alone, at the begginning of the simulation session - Evaluation cognitive load of multitasking, at the end of the simulation session
|
The Official NASA Task Load Index (TLX) is a subjective workload assessment tool.
By incorporating a multi-dimensional rating procedure, NASA TLX derives an overall workload score based on a weighted average of ratings on six subscales: mental demand, physical demand, temporal demand, performance, effort, frustration.
|
A two time points: - Evaluating cognitive load of manual ventilation alone, at the begginning of the simulation session - Evaluation cognitive load of multitasking, at the end of the simulation session
|
|
Time to answer items of the script concordance test (seconds)
Časové okno: Two time points: intervention and control.
|
Time between end of question and beggining of answer for each item of the script concordance test. Evaluates the interruption lag. |
Two time points: intervention and control.
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Sub-group analysis of the primary outcome measure
Časové okno: Two time points: intervention and control.
|
Subgroups:
|
Two time points: intervention and control.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Westbrook JI, Woods A, Rob MI, Dunsmuir WT, Day RO. Association of interruptions with an increased risk and severity of medication administration errors. Arch Intern Med. 2010 Apr 26;170(8):683-90. doi: 10.1001/archinternmed.2010.65.
- Sujka JA, Safcsak K, Bhullar IS, Havron WS 3rd. Simulation-Based Testing of Pager Interruptions During Laparoscopic Cholecystectomy. J Surg Educ. 2018 Sep-Oct;75(5):1351-1356. doi: 10.1016/j.jsurg.2018.01.012. Epub 2018 Feb 1.
- Murji A, Luketic L, Sobel ML, Kulasegaram KM, Leyland N, Posner G. Evaluating the effect of distractions in the operating room on clinical decision-making and patient safety. Surg Endosc. 2016 Oct;30(10):4499-504. doi: 10.1007/s00464-016-4782-4. Epub 2016 Feb 19.
- McCurdie T, Sanderson P, Aitken LM. Traditions of research into interruptions in healthcare: A conceptual review. Int J Nurs Stud. 2017 Jan;66:23-36. doi: 10.1016/j.ijnurstu.2016.11.005. Epub 2016 Nov 10.
- Adams TN, Rho JC. Multitasking simulation: Present application and future directions. Med Teach. 2017 Feb;39(2):120-122. doi: 10.1080/0142159X.2016.1230666. Epub 2016 Sep 15.
- Jackson KM, Shaw TH, Helton WS. Evaluating the dual-task decrement within a simulated environment: Word recall and visual search. Appl Ergon. 2023 Jan;106:103861. doi: 10.1016/j.apergo.2022.103861. Epub 2022 Aug 20.
- Gui JL, Nemergut EC, Forkin KT. Distraction in the operating room: A narrative review of environmental and self-initiated distractions and their effect on anesthesia providers. J Clin Anesth. 2021 Feb;68:110110. doi: 10.1016/j.jclinane.2020.110110. Epub 2020 Oct 16.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RNIPH-2026-CESAR-FOCUS
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Multitasking
-
Centre Hospitalier Universitaire, AmiensUniversity Hospital, Lille; Centre Hospitalier Arras; CH Le Havre; CH Compiègne; CENTRE... a další spolupracovníciNábor