Centre d'Évaluation et de Simulation Alpes Recherche (CESAR)
Grenoble, 38700, France
Location status: Recruiting
Location contact
Alexis Lesage, MD
CONTACT
Jean-Noël Evain, MD, PhD
CONTACT
NCT Number: NCT07615582
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Grenoble, 38700, France
Location status: Recruiting
Alexis Lesage, MD
CONTACT
Jean-Noël Evain, MD, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Simulation training session during which participants will be required to multitask by performing manual mask ventilation on a manikin while answering oral clinical questions administered in the form of Script Concordance Tests (SCTs).
Time frame: 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.
Time frame: - 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.
Time frame: - 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.
Time frame: 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.
Time frame: 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.
Time frame: Two time points: intervention and control.
Subgroups:
Time frame: - Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
Subgroups:
Time frame: Training phase (baseline), simulation phase (ventilation-only and ventilation plus clinical questions)
Contact information is provided by the study sponsor or research team.
Caroline Sanchez, PhD
CONTACT
Jean-Noël Evain, MD, PhD
CONTACT
University Hospital, Grenoble
Other
Acronym: FOCUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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