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

30. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

35

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Frankrike
      • Grenoble, Frankrike, 38700
        • Rekruttering
        • Centre d'Évaluation et de Simulation Alpes Recherche (CESAR)
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
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.
Manual ventilation performance assessed by variance of expiratory tidal volume (ml)
Tidsramme: - 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)
Tidsramme: - 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Exploratory 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.
Exploratory subgroup analyses of expiratory tidal volume variance and respiratory rate variance
Tidsramme: - 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Grenoble

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. juni 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

22. mai 2026

Først innsendt som oppfylte QC-kriteriene

22. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RNIPH-2026-CESAR-FOCUS

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Single center study

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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