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

22. maj 2026 opdateret af: 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 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

35

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

      • Grenoble, Frankrig, 38700
        • Centre d'Évaluation et de Simulation Alpes Recherche (CESAR)
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Concordance score with the expert panel on a Script Concordance Test (SCT)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Manual ventilation performance assessed by deviation from the instructed tidal volume per cycle (milliliters).
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sub-group analysis of the primary outcome measure
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

22. maj 2026

Først indsendt, der opfyldte QC-kriterier

22. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RNIPH-2026-CESAR-FOCUS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Single center study

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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Kliniske forsøg med Anæstesi

Kliniske forsøg med Multitasking

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