- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05619081
Recovery Napping Protocol for Anesthesiologist Performance (R-NAP)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France
- Claude Bernard University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Second to Fifth year of residency
- Completing night shifts at anesthesia/reanimation unit
Exclusion Criteria:
- No Consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NAP GROUP
30min of Powernap before second performance measure
|
POWERNAP of max 30min while participants ly down comfortably
|
|
No Intervention: NO NAP GROUP
30min of free quiet occupation before second performance measure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Score of technical clinical performance via rating grids
Time Frame: 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 days
|
|
Score of Non-Technical clinical performance via Ottawa Crisis Resource Management Scale
Time Frame: 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
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate as physiological stress measure
Time Frame: 2 days
|
Objective stress level during performance measured by duration of heart rate tachycardia (> 100 bpm) measured with ambulatory ECG (Hexoskin)
|
2 days
|
|
Visual analogue scale for the evaluation of psychological stress
Time Frame: 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.
|
2 days
|
|
Reaction time in Alertness task
Time Frame: 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.
|
2 days
|
|
Sleepiness Score
Time Frame: 2 days
|
Karolinska Sleepiness Scale, Score between 1(extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep)
|
2 days
|
|
Pain Empathy Accuracy
Time Frame: 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. |
2 days
|
|
Pain Empathy D prime
Time Frame: 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))
|
2 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jean-Jacques Lehot, PhD, jean-jacques.lehot2@univ-lyon1.fr
Publications and helpful links
General Publications
- Landrigan CP, Rothschild JM, Cronin JW, Kaushal R, Burdick E, Katz JT, Lilly CM, Stone PH, Lockley SW, Bates DW, Czeisler CA. Effect of reducing interns' work hours on serious medical errors in intensive care units. N Engl J Med. 2004 Oct 28;351(18):1838-48. doi: 10.1056/NEJMoa041406.
- Rosekind MR, Gander PH, Gregory KB, Smith RM, Miller DL, Oyung R, Webbon LL, Johnson JM. Managing fatigue in operational settings 2: An integrated approach. Behav Med. 1996 Winter;21(4):166-70. doi: 10.1080/08964289.1996.9933754.
- Nollet M, Wisden W, Franks NP. Sleep deprivation and stress: a reciprocal relationship. Interface Focus. 2020 Jun 6;10(3):20190092. doi: 10.1098/rsfs.2019.0092. Epub 2020 Apr 17.
- Ehooman F, Wildenberg L, Manquat E, Makoudi S, Demiri S, Carbonne H, Bardon J. Connected devices to evaluate sleep, physical activity and stress pattern of anaesthesiology and intensive care residents. Eur J Anaesthesiol. 2020 Jul;37(7):616-618. doi: 10.1097/EJA.0000000000001207. No abstract available.
- Stewart NH, Arora VM. The Impact of Sleep and Circadian Disorders on Physician Burnout. Chest. 2019 Nov;156(5):1022-1030. doi: 10.1016/j.chest.2019.07.008. Epub 2019 Jul 25.
- Howard SK, Gaba DM, Smith BE, Weinger MB, Herndon C, Keshavacharya S, Rosekind MR. Simulation study of rested versus sleep-deprived anesthesiologists. Anesthesiology. 2003 Jun;98(6):1345-55; discussion 5A. doi: 10.1097/00000542-200306000-00008.
- 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.
- Dutheil F, Bessonnat B, Pereira B, Baker JS, Moustafa F, Fantini ML, Mermillod M, Navel V. Napping and cognitive performance during night shifts: a systematic review and meta-analysis. Sleep. 2020 Dec 14;43(12):zsaa109. doi: 10.1093/sleep/zsaa109.
- Dutheil F, Danini B, Bagheri R, Fantini ML, Pereira B, Moustafa F, Trousselard M, Navel V. Effects of a Short Daytime Nap on the Cognitive Performance: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Sep 28;18(19):10212. doi: 10.3390/ijerph181910212.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-NAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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