- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02622217
Impact of Sleep Deprivation on Anesthesiology Residents' Non-technical Skills
May 10, 2016 updated by: Arthur Neuschwander, University of Paris 5 - Rene Descartes
Impact of Sleep Deprivation on Anesthesiology Residents' Non-technical Skills: a Simulation Based Randomised Study.
Sleep deprivation is common in anaesthesiology residents.
Its effects on technical skills have been reported with controversial results.
Non-technical skills (team working, situation awareness, decision making and task management) contribute to safe and efficient task performance.
They have a crucial role in anaesthetic practice, especially during crisis management.
The investigators hypothesized that sleep deprivation was associated with a reduced mobilisation of non-technical skills in anaesthesiology residents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The scenario consisted in a rapid sequence induction for emergency general anaesthesia in case of acute peritonitis complicated by an anaphylactic shock secondary to the injection of succinylcholine.
All scenarios were performed with the assistance of an anaesthetist nurse, facilitator of the scenario.
In a second time, after patient stabilisation (defined as oxygen saturation by pulse oximetry (SpO2) > 95%, mean arterial pressure (PAM) > 65 mmHg and heart rate (HR) < 100 bpm for at least 2 minutes) consecutive to an expected injection of 100 µg of epinephrine decided by the participant, a surgeon entered the operating room to create a dilemma regarding patient destination (continue surgery or intensive care unit admission)
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Anesthesiology residents from Paris academic hospitals
Exclusion Criteria:
- Chronic sleep disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleep deprived
Participants undergo a simulation session after an on call night
|
|
No Intervention: Rested
Participants undergo a simulation session after a night of normal sleep at home
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anesthetists non technical skills (ANTS) scale
Time Frame: day 0 during procedure
|
score assessed by 2 blinded evaluators during scenario
|
day 0 during procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical skills
Time Frame: day 0 during procedure
|
Check list of items, assessed by 2 blinded evaluators during scenario
|
day 0 during procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
November 28, 2015
First Submitted That Met QC Criteria
December 1, 2015
First Posted (Estimate)
December 4, 2015
Study Record Updates
Last Update Posted (Estimate)
May 11, 2016
Last Update Submitted That Met QC Criteria
May 10, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UParis5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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