HENKEME Mathieu
Lyon, Auvergne-Rhône-Alpes, 69008, France
NCT Number: NCT06487208
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Lyon, Auvergne-Rhône-Alpes, 69008, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of a digital cognitive aid in order to anticipate a critical situation
No intervention
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).
Time frame: One day after simulation
performance score from 0 minimum to a maximum of 100
Time frame: One day after simulation
performance score from 0 minimum to a maximum of 100
Time frame: 2 minutes before simulation
Visual analog scale from 0 minimum to 100 maximum
Time frame: 2 minutes after simulation
Visual analog scale from 0 minimum to 100 maximum
Time frame: 2 minutes after simulation
Visual analog scale from 0 minimum to 100 maximum
Time frame: 2 minutes after simulation
Visual analog scale from 0 minimum to 100 maximum
Claude Bernard University
Other
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
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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