- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a prospective, single-center, non-interventional study. The study was classified as non-interventional by the institutional research committee, as the intervention consists of simulation training and the study population comprises healthcare practitioners.
The study participants are anesthesiologists, including 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 performing manual mask ventilation on a manikin while answering oral clinical questions administered in the form of Script Concordance Tests (SCTs). Participants will be instructed to ventilate the manikin with a tidal volume of 500 mL and a respiratory rate of 15 breaths/minute.
Clinical reasoning under quiet conditions will 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. The 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. Five vignettes will be allocated to the intervention condition and fifteen to the control condition. 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 in both the simulation and control conditions.
Detailed information is available in the study protocol.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jean-Noël Evain, MD, PhD
- Número de teléfono: +33476766829
- Correo electrónico: jnevain@chu-grenoble.fr
Copia de seguridad de contactos de estudio
- Nombre: Caroline Sanchez, PhD
- Número de teléfono: 0476766829
- Correo electrónico: csanchez5@chu-grenoble.fr
Ubicaciones de estudio
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Grenoble, Francia, 38700
- Reclutamiento
- Centre d'Évaluation et de Simulation Alpes Recherche (CESAR)
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Contacto:
- Jean-Noël Evain, MD, PhD
- Número de teléfono: 0476766829
- Correo electrónico: jnevain@chu-grenoble.fr
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Contacto:
- Alexis Lesage, MD
- Número de teléfono: 0476766829
- Correo electrónico: ALesage@chu-grenoble.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Anesthesiology and intensive care resident or attending physician
- Written informed consent
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Concordance score with the expert panel on a Script Concordance Test (SCT)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to answer items of the script concordance test (seconds)
Periodo de tiempo: 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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Manual ventilation performance assessed by variance of expiratory tidal volume (ml)
Periodo de tiempo: - Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
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Participants will be instructed to ventilate with an expiratory tidal volume (Vte) between 450 and 500 mL at a respiratory rate of 15 breaths per minute.
Variability in Vte will be used as an indicator of the difficulty in complying with these instructions.
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- Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
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Manual ventilation performance assessed by variance of respiratory rate (cycles/minute)
Periodo de tiempo: - Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
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Participants will be instructed to ventilate with an expiratory tidal volume (Vte) between 450 and 500 mL at a respiratory rate of 15 breaths per minute.
Variability in respiratory rate will be used as an indicator of the difficulty in complying with these instructions.
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- Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
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Cognitive load assessed by the NASA-TLX index (score out of 100)
Periodo de tiempo: A two time points: - Evaluating cognitive load of manual ventilation alone, before simulation after training. - 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, before simulation after training. - Evaluation cognitive load of multitasking, at the end of the simulation session
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Exploratory sub-group analysis of the primary outcome measure
Periodo de tiempo: 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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Exploratory subgroup analyses of expiratory tidal volume variance and respiratory rate variance
Periodo de tiempo: - Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
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Subgroups:
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- Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
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Descriptive analysis of ventilation parameters
Periodo de tiempo: Training phase (baseline), simulation phase (ventilation-only and ventilation plus clinical questions)
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Training phase (baseline), simulation phase (ventilation-only and ventilation plus clinical questions)
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RNIPH-2026-CESAR-FOCUS
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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