Clinical trial NCT06487208: Impact of a Hand-held Digital Cognitive Aid to Anticipated a Simulated Crisis Situation for Resident
Official title: AnticipaMax: Impact of the Use of a Hand-held Digital Cognitive Aid in Order to Anticipated a Potential Crisis Situation, Measured by a Composite Globale Performance Score, in Anesthesia Resident
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Anticipation
Cognitive aid
Critical situation
Simulation
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed description: Context: Over the past few decades, considerable efforts have been made to understand and manage risks, especially in high stakes sectors such as aviation and the nuclear industry. However, risk management in the medical field, such as anesthesia and critical care, is still in its infancy. Complex activities like anesthesia and critical care are prone to human errors, exacerbate by factors such as lack of sleep and stress.

Despite the inevitable risk of errors, solution exist to reduce them, including the use of cognitive aids such as the digital application MAX or the SFAR paper checklists. The value of these aids is well documented and supported by extensive literature. Nevertheless, those tools are still underutilized in clinical practice, likely due to negative perceptions and, a lack of familiarity among doctors.

Thus, the investigators believe that the systematic anticipation of perioperative complications and their management through a digital cognitive aid in daily practice could improve patient care by enhancing the overall performance of doctors and healthcare teams.

Primary objective: Demonstrate that the systematic anticipation of potential major perioperative complications, by using a digital cognitive aid, improves global performance in managing a critical situation. The primary outcome is measure with a composite score including both technical and no technical performance.

Secondary objectives: Several secondary outcomes measures: Comparison between the two groups of the technical and no technical performance. Stress during the simulation, self confidence level, the difference between the required competency level and the level that participant estimates have. And evaluation of biological stress response through sympathetic and parasympathetic indices calculated from electrophysiological variables via a connected watch.

Nature and conduct of the study: A prospective, randomized, controlled, single center study (Lyon). The study will be conducted in simulation at CLESS (Claude Bernard University Lyon 1) with participants being anesthesia and critical care residents in the consolidation and advanced phases. A single scenario will be used for the study. Each resident will be randomized into either the interventional group (anticipaMAX) or the control group. The intervention will take place during the five minutes preceding the start of the scenario. During this period, volunteers in the interventional group will be instructed to use the five minutes to consider potential complications and anticipate their management with the help of the MAX tool. Volunteers in the control group will be free to organize themselves as they wish, with the same medical file elements and the MAX application at their disposal. During the scenario, facilitator intervention will be standardized to ensure the comparability between the two groups.

Eligibility criteria: Inclusion Criteria:

* Anesthesia Resident of Lyon

Exclusion Criteria:

* First Year of anesthesia residency

Primary outcomes:
measure: Global performance composite score
timeFrame: one day after simulation
Secondary outcomes:
measure: Technical performance
timeFrame: One day after simulation
measure: Non technical performance
timeFrame: One day after simulation
measure: Stress level, self-evaluated
timeFrame: 2 minutes before simulation
measure: Stress level, self-evaluated
timeFrame: 2 minutes after simulation
measure: Self confidence level
timeFrame: 2 minutes after simulation
measure: Difference between the required competency level and the level that participant estimates have
timeFrame: 2 minutes after simulation
Other outcomes:
Locations:
city: Lyon
country: France
facility: HENKEME Mathieu
state: Rhone Alpes
Study officials:
affiliation: Université Claude Bernard Lyon 1
name: Jean-Christophe Cejka, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.