Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487208
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-05
First Post:
2024-06-14
Brief Title:
Impact of a Hand-held Digital Cognitive Aid to Anticipated a Simulated Crisis Situation for Resident
Sponsor:
Claude Bernard University
Organization:
Claude Bernard University
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AnticipaMax
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None