- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jean-Noël Evain, MD, PhD
- Phone Number: +33476766829
- Email: jnevain@chu-grenoble.fr
Study Contact Backup
- Name: Caroline Sanchez, PhD
- Phone Number: 0476766829
- Email: csanchez5@chu-grenoble.fr
Study Locations
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-
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Grenoble, France, 38700
- Recruiting
- Centre d'Évaluation et de Simulation Alpes Recherche (CESAR)
-
Contact:
- Jean-Noël Evain, MD, PhD
- Phone Number: 0476766829
- Email: jnevain@chu-grenoble.fr
-
Contact:
- Alexis Lesage, MD
- Phone Number: 0476766829
- Email: ALesage@chu-grenoble.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Anesthesiology and intensive care resident or attending physician
- Written informed consent
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concordance score with the expert panel on a Script Concordance Test (SCT)
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.
|
At two time points: - During simulation session under multitasking conditions - During control visit under quiet conditions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to answer items of the script concordance test (seconds)
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. |
Two time points: intervention and control.
|
|
Manual ventilation performance assessed by variance of expiratory tidal volume (ml)
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.
|
- Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
|
|
Manual ventilation performance assessed by variance of respiratory rate (cycles/minute)
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.
|
- Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
|
|
Cognitive load assessed by the NASA-TLX index (score out of 100)
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.
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exploratory sub-group analysis of the primary outcome measure
Time Frame: Two time points: intervention and control.
|
Subgroups:
|
Two time points: intervention and control.
|
|
Exploratory subgroup analyses of expiratory tidal volume variance and respiratory rate variance
Time Frame: - Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
|
Subgroups:
|
- Training before simulation: baseline - During simulation: ventilation only, ventilation plus clinical questions
|
|
Descriptive analysis of ventilation parameters
Time Frame: Training phase (baseline), simulation phase (ventilation-only and ventilation plus clinical questions)
|
|
Training phase (baseline), simulation phase (ventilation-only and ventilation plus clinical questions)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNIPH-2026-CESAR-FOCUS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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