Impact of a Hand-held Digital Cognitive Aid to Anticipated a Simulated Crisis Situation for Resident

NCT06487208 | Completed Phase 4

• 1 other identifier: AnticipaMax
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to demonstrate that the systematic anticipation of major potential per operative complications using a digital cognitive aid and visualizing the appropriate actions in such cases leads to an improvement in overall performance during an immediate critical situation in simulation, particularly through the regular reassessment of the initial hypothesis

Conditions

Healthy

Keywords

Anticipation; Cognitive aid; Critical situation; Simulation

Outcome Measures

Primary Outcomes (1)

• Global performance composite score

  The primary outcome measure is a composite score of overall performance, based on both technical performance and non-technical performance, assessed by a validated scale (Ottawa Crisis Resource Management) demonstrated by the included subject during the full-scale simulation after the implementation of the intervention. Composite score of technical performance on a scale of 100 + non-technical performance on a scale of 0 minimum to a maximum of 100, therefore a total from zero minimum to 200 hundred maximum. To obtain this composite score, we will sum the technical performance score out of 100 points and the non-technical performance score out of 100 points (Ottawa scale / 42 points, converted to a score out of 100).

  one day after simulation

Secondary Outcomes (6)

• Technical performance

  One day after simulation

• Non technical performance

  One day after simulation

• Stress level, self-evaluated

  2 minutes before simulation

• Stress level, self-evaluated

  2 minutes after simulation

• Self confidence level

  2 minutes after simulation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

No intervention

Other: Placebo

AnticipaMax

EXPERIMENTAL

The subjects will be instructed to use the 5 minutes to consider potential complications, prioritize them, and anticipate their management. The facilitators will have a neutral role with pre-determined standardized responses and will ensure the correct use of the Max tool during this time period

Other: Use of a digital cognitive aid in order to anticipate a critical situation

Interventions

Use of a digital cognitive aid in order to anticipate a critical situation OTHER

Use of a digital cognitive aid in order to anticipate a critical situation

AnticipaMax

Placebo OTHER

No intervention

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anesthesia Resident of Lyon

You may not qualify if:

• First Year of anesthesia residency

Sponsors & Collaborators

• Claude Bernard University: lead

Study Sites (1)

HENKEME Mathieu

Lyon, Auvergne-Rhône-Alpes, 69008, France

Location

Related Publications (5)

• Evain JN, Perrot A, Vincent A, Cejka JC, Bauer C, Duclos A, Rimmele T, Lehot JJ, Lilot M. Team planning discussion and clinical performance: a prospective, randomised, controlled simulation trial. Anaesthesia. 2019 Apr;74(4):488-496. doi: 10.1111/anae.14602. Epub 2019 Feb 15.

  PMID: 30768684 BACKGROUND

• Paraschiv AP, Balanca B, Lilot M, Aigle L, Lehot JJ, Cejka JC. Use of a Digital Cognitive Aid Improves Memorization of Military Caregivers After High-Fidelity Simulations of Combat Casualty Care. Mil Med. 2023 Jan 4;188(1-2):e295-e300. doi: 10.1093/milmed/usab175.

  PMID: 33928372 BACKGROUND

• Truchot M, Balanca B, Wey PF, Tazarourte K, Lecomte F, Le Goff A, Leigh-Smith S, Lehot JJ, Rimmele T, Cejka JC. Use of a Digital Cognitive Aid in the Early Management of Simulated War Wounds in a Combat Environment, a Randomized Trial. Mil Med. 2020 Aug 14;185(7-8):e1077-e1082. doi: 10.1093/milmed/usz482.

  PMID: 32091610 BACKGROUND

• Claverie D, Trousselard M, Sigwalt F, Petit G, Evain JN, Bui M, Guinet-Lebreton A, Chassard D, Duclos A, Lehot JJ, Rimmele T, Canini F, Lilot M. Impact of stress management strategies and experience on electrodermal activity during high-fidelity simulation of critical situations. Br J Anaesth. 2020 Nov;125(5):e410-e412. doi: 10.1016/j.bja.2020.07.024. Epub 2020 Aug 21. No abstract available.

  PMID: 32838978 BACKGROUND

• Lelaidier R, Balanca B, Boet S, Faure A, Lilot M, Lecomte F, Lehot JJ, Rimmele T, Cejka JC. Use of a hand-held digital cognitive aid in simulated crises: the MAX randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):1015-1021. doi: 10.1093/bja/aex256.

  PMID: 29028930 BACKGROUND

Study Officials

• Jean-Christophe Cejka, Ph.D

  Université Claude Bernard Lyon 1

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 5, 2024
• Study Start: March 7, 2024
• Primary Completion: October 5, 2024
• Study Completion: December 12, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

FR (1)