- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jean-Noël Evain, MD, PhD
- Numer telefonu: +33476766829
- E-mail: jnevain@chu-grenoble.fr
Kopia zapasowa kontaktu do badania
- Nazwa: Caroline Sanchez, PhD
- Numer telefonu: 0476766829
- E-mail: csanchez5@chu-grenoble.fr
Lokalizacje studiów
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Grenoble, Francja, 38700
- Centre d'Évaluation et de Simulation Alpes Recherche (CESAR)
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Kontakt:
- Jean-Noël Evain, MD, PhD
- Numer telefonu: 0476766829
- E-mail: jnevain@chu-grenoble.fr
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Kontakt:
- Alexis Lesage, MD
- Numer telefonu: 0476766829
- E-mail: ALesage@chu-grenoble.fr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Anesthesiology and intensive care resident or attending physician
- Written informed consent
Exclusion Criteria:
- None
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Concordance score with the expert panel on a Script Concordance Test (SCT)
Ramy czasowe: At two time points: - During simulation session under multitasking conditions - During control visit under quiet conditions
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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.
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At two time points: - During simulation session under multitasking conditions - During control visit under quiet conditions
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Manual ventilation performance assessed by deviation from the instructed tidal volume per cycle (milliliters).
Ramy czasowe: During simulation, comparison between manual ventilation interrupted by clinical questions versus manual ventilation alone
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│Instructed tidal volume- Observed tidal volume│/ cycle (milliliters)
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During simulation, comparison between manual ventilation interrupted by clinical questions versus manual ventilation alone
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Manual ventilation performance assessed by deviation from the instructed respiratory rate (cycles/minutes).
Ramy czasowe: During simulation, comparison between manual ventilation interrupted by clinical questions versus manual ventilation alone
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│Instructed respiratory rate- Observed respiratory rate│
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During simulation, comparison between manual ventilation interrupted by clinical questions versus manual ventilation alone
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Cognitive load assessed by the NASA-TLX index (score out of 100)
Ramy czasowe: 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
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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.
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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
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Time to answer items of the script concordance test (seconds)
Ramy czasowe: Two time points: intervention and control.
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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.
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Sub-group analysis of the primary outcome measure
Ramy czasowe: Two time points: intervention and control.
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Subgroups:
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Two time points: intervention and control.
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- RNIPH-2026-CESAR-FOCUS
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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