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Recruiting NCT07427641

Effect of Visual Deprivation of the Team Leader on Team Performance During Simulated Medical Emergencies

No phase Interventional High Fidelity Simulation Training Randomized Controlled Trials Education, Medical, Continuing Education, Medical

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Visual deprivation.
Who it may be relevant to
Registry conditions: High Fidelity Simulation Training, Randomized Controlled Trials, Education, Medical, Continuing, Education, Medical. Basic parameters: 25 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

LEADE ME: Effect of Visual Deprivation of the Team Leader on Team Performance During Simulated Medical Emergencies - A Multicenter Randomized Controlled Study

Overview

This multicenter randomized controlled study aims to evaluate the impact of temporary visual deprivation of the medical team leader on non-technical skills and team performance during high-fidelity simulated medical emergencies. The intervention is based on principles of crisis resource management and cognitive load theory. Team performance will be assessed using validated scoring tools immediately after the intervention and at three months follow-up.

Interventions

  • Behavioral Visual deprivation
    The designated team leader performs the simulated scenario while wearing visual deprivation mask

Primary outcome measures

  • Evolution of team performance on non-technicals skills [Time frame: Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month]
Secondary outcome measures (5)
  • Evolution of team's clinical performance [Time frame: Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month]
  • Evolution of medical leadership skills [Time frame: Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month]
  • Clinical transferability of soft skills training in clinical practice [Time frame: Immediately after the intervention at day 1 and at 3 month]
  • Evolution of theoretical knowledge of soft skills [Time frame: At the end of the intervention at day 1 and at 3 month]
  • Assessment of anxiety induced by the intervention [Time frame: At the end of the intervention at day 1]

Eligibility criteria

The teams participating in the simulation sessions are composed as follows:

  • A senior doctor identified as the "medical leader"
  • An anaesthesia and intensive care intern
  • A state-registered nurse anaesthetist

Inclusion criteria

  • Participants with at least two years' experience in the specialty.

a. For interns, an additional requirement is that they must have completed a semester in intensive care.

  • Recruited via simulation trainers at their respective hospitals or university hospitals.

Exclusion criteria

  • The study cannot be carried out during a safety rest period (i.e. the day after being on call).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

France · 1 center
  • Rennes University Hospital — Rennes

Identifiers

NCT: NCT07427641 · 35RC25-T4818_LEADME

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗