Recovery Napping Protocol for Anesthesiologist Performance (R-NAP)
Primary Purpose
Sleep Deprivation, Critical Incident, Sleep
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
POWERNAP
Sponsored by
About this trial
This is an interventional health services research trial for Sleep Deprivation focused on measuring Power-napping, High Fidelity Simulation, Night Shift, Clinical Performance
Eligibility Criteria
Inclusion Criteria: Second to Fifth year of residency Completing night shifts at anesthesia/reanimation unit Exclusion Criteria: No Consent
Sites / Locations
- Claude Bernard University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NAP GROUP
NO NAP GROUP
Arm Description
30min of Powernap before second performance measure
30min of free quiet occupation before second performance measure
Outcomes
Primary Outcome Measures
Score of technical clinical performance via rating grids
Technical clinical performance according to a standardizes grid (Score from 0 to 100) for each critical care scenario evaluated by experts based on the video. Higher scores indicate better performance
Score of Non-Technical clinical performance via Ottawa Crisis Resource Management Scale
Non-technical clinical performance rated by experts based on the video from 6 to 42 of the Ottawa Crisis Resource Management Scale. Higher scores indicate better performance
Secondary Outcome Measures
Heart Rate as physiological stress measure
Objective stress level during performance measured by duration of heart rate tachycardia (> 100 bpm) measured with ambulatory ECG (Hexoskin)
Visual analogue scale for the evaluation of psychological stress
Subjective stress level during performance measured with visual analogue scales (VAS) on 100mm from zero intensity to maximal intensity. High stress levels are worse.
Reaction time in Alertness task
Computerized alertness test named SART (Sustained Attention to Response Task) programmed based on psytoolkit, 150 trials in test phase. Faster speed (low RT) for correct responses indicates a better performance.
Sleepiness Score
Karolinska Sleepiness Scale, Score between 1(extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep)
Pain Empathy Accuracy
Capacity to distinguish painful and non painful faces according to a computerized pre-validated pain empathy test.
Accuracy rates for hits and false alarms will be computed in percent: ((hits + correct rejections) / total responses). HIgher percentages indicate better performance.
Pain Empathy D prime
Capacity to distinguish painful and non painful faces according to a computerized pre-validated pain empathy test. Also d prime as sensitivity score will provide a score on how well participants were able to distinguish the presence of the signal (pain) from the absence (non pain). The higher d prime the better (d' = z(H) - z(F))
Full Information
NCT ID
NCT05619081
First Posted
September 30, 2022
Last Updated
August 26, 2023
Sponsor
Claude Bernard University
1. Study Identification
Unique Protocol Identification Number
NCT05619081
Brief Title
Recovery Napping Protocol for Anesthesiologist Performance
Acronym
R-NAP
Official Title
Recovery Napping Protocol for Anesthesiologist Performance
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Claude Bernard University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sleep deprivation impacts performance of shift workers in health care. Anesthesiologists are a population at risk that endures stressful situations and changing working hours. The decreased performance could be the cause for undesirable events. Power-napping is known to be an efficient technique to mitigate the detrimental effects of sleep deprivation and is a feasible measure to implement in critical care units. Still there are few insights that measure the clinical relevance in the field. With the high-fidelity simulations this study is able to measure clinical performance and test for those effects. Therefore we propose a prospective, monocentric study to evaluate a power-napping protocol (less than 30min)
Detailed Description
Residents in anesthesiology will be recruited on voluntary basis. They will pass the high fidelity simulation twice, once as a baseline measure under normal conditions after a typical night at home and once sleep deprived after a night shift.
BASELINE Participants will wear actigraphy bracelets to define their sleep pattern for 2 weeks, Then they will spent a normal night at home before coming to the performance center in the afternoon (13h to18h). There they will respond to questions about stress and sleep, will be equipped with smart shirts (HEXOSKIN) to measure their level of stress during the performance, and then undertake a crisis simulation. Afterwards they pass some standardized cognitive tests.
TRAINING The whole year group of residents will be trained to understand sleep management and learn power napping. After the workshop they will individually be trained during 2 weeks including some follow up calls.
INTERVENTION The participants carry again actigraphy bracelets. Then they work a night shift in their service where they usually sleep less than four hours. The morning after the shift participants are free to spend how the like while sleep is being controlled with actigraphy bracelets. In the afternoon (13 to 18h) they return for the second time to the performance center. They are randomly assigned to a napping or non napping group and equipped with ambulatory ECG (Hexoskin) as well es ambulatory EEG (Somfit). After the intervention period (nap or leisure time) they proceed with the same performance measures as at baseline including a simulation crisis and computerized cognitive tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Critical Incident, Sleep, Anesthesia
Keywords
Power-napping, High Fidelity Simulation, Night Shift, Clinical Performance
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Control Trial (RCT)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NAP GROUP
Arm Type
Experimental
Arm Description
30min of Powernap before second performance measure
Arm Title
NO NAP GROUP
Arm Type
No Intervention
Arm Description
30min of free quiet occupation before second performance measure
Intervention Type
Behavioral
Intervention Name(s)
POWERNAP
Intervention Description
POWERNAP of max 30min while participants ly down comfortably
Primary Outcome Measure Information:
Title
Score of technical clinical performance via rating grids
Description
Technical clinical performance according to a standardizes grid (Score from 0 to 100) for each critical care scenario evaluated by experts based on the video. Higher scores indicate better performance
Time Frame
2 days
Title
Score of Non-Technical clinical performance via Ottawa Crisis Resource Management Scale
Description
Non-technical clinical performance rated by experts based on the video from 6 to 42 of the Ottawa Crisis Resource Management Scale. Higher scores indicate better performance
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Heart Rate as physiological stress measure
Description
Objective stress level during performance measured by duration of heart rate tachycardia (> 100 bpm) measured with ambulatory ECG (Hexoskin)
Time Frame
2 days
Title
Visual analogue scale for the evaluation of psychological stress
Description
Subjective stress level during performance measured with visual analogue scales (VAS) on 100mm from zero intensity to maximal intensity. High stress levels are worse.
Time Frame
2 days
Title
Reaction time in Alertness task
Description
Computerized alertness test named SART (Sustained Attention to Response Task) programmed based on psytoolkit, 150 trials in test phase. Faster speed (low RT) for correct responses indicates a better performance.
Time Frame
2 days
Title
Sleepiness Score
Description
Karolinska Sleepiness Scale, Score between 1(extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep)
Time Frame
2 days
Title
Pain Empathy Accuracy
Description
Capacity to distinguish painful and non painful faces according to a computerized pre-validated pain empathy test.
Accuracy rates for hits and false alarms will be computed in percent: ((hits + correct rejections) / total responses). HIgher percentages indicate better performance.
Time Frame
2 days
Title
Pain Empathy D prime
Description
Capacity to distinguish painful and non painful faces according to a computerized pre-validated pain empathy test. Also d prime as sensitivity score will provide a score on how well participants were able to distinguish the presence of the signal (pain) from the absence (non pain). The higher d prime the better (d' = z(H) - z(F))
Time Frame
2 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Second to Fifth year of residency
Completing night shifts at anesthesia/reanimation unit
Exclusion Criteria:
No Consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Lehot, PhD
Organizational Affiliation
jean-jacques.lehot2@univ-lyon1.fr
Official's Role
Study Chair
Facility Information:
Facility Name
Claude Bernard University
City
Lyon
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8731493
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Arzalier-Daret S, Buleon C, Bocca ML, Denise P, Gerard JL, Hanouz JL. Effect of sleep deprivation after a night shift duty on simulated crisis management by residents in anaesthesia. A randomised crossover study. Anaesth Crit Care Pain Med. 2018 Apr;37(2):161-166. doi: 10.1016/j.accpm.2017.05.010. Epub 2017 Sep 4.
Results Reference
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Citation
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Results Reference
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Recovery Napping Protocol for Anesthesiologist Performance
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