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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
Claude Bernard University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
September 30, 2022
Last Updated
August 26, 2023
Sponsor
Claude Bernard University
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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
32382403
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
31352036
Citation
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.
Results Reference
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PubMed Identifier
15509817
Citation
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.
Results Reference
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PubMed Identifier
12766642
Citation
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.
Results Reference
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PubMed Identifier
28882740
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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PubMed Identifier
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Citation
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.
Results Reference
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Citation
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.
Results Reference
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Recovery Napping Protocol for Anesthesiologist Performance

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