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Completed

NCT Number: NCT06487208

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HENKEME Mathieu

Lyon, Auvergne-Rhône-Alpes, 69008, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Anesthesia Resident of Lyon

Exclusion criteria

  • First Year of anesthesia residency

Treatment and study plan

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

Placebo

Other

No intervention

Primary outcomes

  1. Global performance composite score

    Time frame: one day after simulation

    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).

Secondary outcomes

  1. Technical performance

    Time frame: One day after simulation

    performance score from 0 minimum to a maximum of 100

  2. Non technical performance

    Time frame: One day after simulation

    performance score from 0 minimum to a maximum of 100

  3. Stress level, self-evaluated

    Time frame: 2 minutes before simulation

    Visual analog scale from 0 minimum to 100 maximum

  4. Stress level, self-evaluated

    Time frame: 2 minutes after simulation

    Visual analog scale from 0 minimum to 100 maximum

  5. Self confidence level

    Time frame: 2 minutes after simulation

    Visual analog scale from 0 minimum to 100 maximum

  6. Difference between the required competency level and the level that participant estimates have

    Time frame: 2 minutes after simulation

    Visual analog scale from 0 minimum to 100 maximum

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Registry information

Official study 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

Acronym: AnticipaMax

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2024
Registry last updated
Jan 28, 2025

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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