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Clinical Performance and Multitasking in Anesthesia : a Simulation-based Study (FOCUS)

30 de junio de 2026 actualizado por: University Hospital, Grenoble

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

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

De observación

Inscripción (Estimado)

35

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

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

Ubicaciones de estudio

      • Grenoble, Francia, 38700
        • Reclutamiento
        • Centre d'Évaluation et de Simulation Alpes Recherche (CESAR)
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

The study population consists of a sample of anesthesiology and intensive care physicians working at Grenoble University Hospital.

Descripción

Inclusion Criteria:

  • Anesthesiology and intensive care resident or attending physician
  • Written informed consent

Exclusion Criteria:

  • None

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to answer items of the script concordance test (seconds)
Periodo de tiempo: 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.
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
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.
- Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
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
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.
- Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
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
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, before simulation after training. - Evaluation cognitive load of multitasking, at the end of the simulation session

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Exploratory sub-group analysis of the primary outcome measure
Periodo de tiempo: Two time points: intervention and control.

Subgroups:

  • Clinical experience in anesthesiology < or >= 5 semesters
  • Left handed or right handed
  • Musical practice < or >= 5 years
  • Need for cognition scale (18 questions): < or >= median of the group score
Two time points: intervention and control.
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

Subgroups:

  • Clinical experience in anesthesiology < or >= 5 semesters
  • Left handed or right handed
  • Musical practice < or >= 5 years
  • Need for cognition scale (18 questions): < or >= median of the group score
- Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
Descriptive analysis of ventilation parameters
Periodo de tiempo: Training phase (baseline), simulation phase (ventilation-only and ventilation plus clinical questions)
  • Inspiratory tidal volume (ml)
  • Expiratory tidal volume (ml)
  • Respiratory rate (cycles/minute)
  • Resumption lag: time required to re-establish stable ventilation following interruption (seconds)
Training phase (baseline), simulation phase (ventilation-only and ventilation plus clinical questions)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de junio de 2026

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

22 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2026

Publicado por primera vez (Actual)

29 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de junio de 2026

Última verificación

1 de junio de 2026

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)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Single center study

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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