R-NAP: Recovery Napping Protocol for Anesthesiologist Performance

Sponsor
Claude Bernard University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05619081
Collaborator
(none)
52
1
2
13.7
3.8

Study Details

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)

Condition or Disease Intervention/Treatment Phase
  • Behavioral: POWERNAP
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised Control Trial (RCT)Randomised Control Trial (RCT)
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Recovery Napping Protocol for Anesthesiologist Performance
Actual Study Start Date :
Nov 8, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: NAP GROUP

30min of Powernap before second performance measure

Behavioral: POWERNAP
POWERNAP of max 30min while participants ly down comfortably

No Intervention: NO NAP GROUP

30min of free quiet occupation before second performance measure

Outcome Measures

Primary Outcome Measures

  1. Score of technical clinical performance via rating grids [2 days]

    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

  2. Score of Non-Technical clinical performance via Ottawa Crisis Resource Management Scale [2 days]

    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

  1. Heart Rate as physiological stress measure [2 days]

    Objective stress level during performance measured by duration of heart rate tachycardia (> 100 bpm) measured with ambulatory ECG (Hexoskin)

  2. Visual analogue scale for the evaluation of psychological stress [2 days]

    Subjective stress level during performance measured with visual analogue scales (VAS) on 100mm from zero intensity to maximal intensity. High stress levels are worse.

  3. Reaction time in Alertness task [2 days]

    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.

  4. Sleepiness Score [2 days]

    Karolinska Sleepiness Scale, Score between 1(extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep)

  5. Pain Empathy Accuracy [2 days]

    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.

  6. Pain Empathy D prime [2 days]

    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))

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Second to Fifth year of residency

  • Completing night shifts at anesthesia/reanimation unit

Exclusion Criteria:
  • No Consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Claude Bernard University Lyon France

Sponsors and Collaborators

  • Claude Bernard University

Investigators

  • Study Chair: Jean-Jacques Lehot, PhD, jean-jacques.lehot2@univ-lyon1.fr

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lilot Marc, M.D PhD, Principal Investigator, Claude Bernard University
ClinicalTrials.gov Identifier:
NCT05619081
Other Study ID Numbers:
  • R-NAP
First Posted:
Nov 16, 2022
Last Update Posted:
Nov 16, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lilot Marc, M.D PhD, Principal Investigator, Claude Bernard University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2022