Sleep DeprivationNCT02622217
Impact of Sleep Deprivation on Anesthesiology Residents' Non-technical Skills
A study testing Sleep deprivation in people with Sleep Deprivation, run by University of Paris 5 - Rene Descartes.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Sleep deprivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anesthesiology residents from Paris academic hospitals
Who cannot join
- Chronic sleep disorder
About this study
Official title: 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.
Read the 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)
- Conditions
- Sleep Deprivation
- Being tested
- Sleep deprivation
- Keywords
- anesthesiology, non technical kills
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Sleep deprived | Experimental | Participants undergo a simulation session after an on call night Receives: Behavioral: Sleep deprivation |
| Rested | No intervention | Participants undergo a simulation session after a night of normal sleep at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetists non technical skills (ANTS) scale
score assessed by 2 blinded evaluators during scenario
Measured: day 0 during procedure
Secondary outcomes (1)
Technical skills
Check list of items, assessed by 2 blinded evaluators during scenario
Measured: day 0 during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Neuschwander, University of Paris 5 - Rene Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622217
- Sponsor's protocol ID
- UParis5
- Status last verified
- Mar 2025
- First submitted
- 28 Nov 2015
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Neuschwander A, Job A, Younes A, Mignon A, Delgoulet C, Cabon P, Mantz J, Tesniere A. Impact of sleep deprivation on anaesthesia residents' non-technical skills: a pilot simulation-based prospective randomized trial. Br J Anaesth. 2017 Jul 1;119(1):125-131. doi: 10.1093/bja/aex155.
PubMed 28974071
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Deprivation on Anesthesiology Residents' Non-technical Skills: a Simulation Based Randomised Study.
- ClinicalTrials.gov ID
- NCT02622217
- Acronym / sponsor ID
- UParis5
- Conditions
- Sleep Deprivation
- Keywords
- anesthesiology, non technical kills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep deprived | Experimental | Behavioral: Sleep deprivationParticipants undergo a simulation session after an on call night |
| Rested | No intervention | –Participants undergo a simulation session after a night of normal sleep at home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesiology residents from Paris academic hospitals
Key exclusion criteria (1 listed)
- Chronic sleep disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep deprivation | Behavioural | Sleep deprived |
Primary outcome
Anesthetists non technical skills (ANTS) scale
Time frame: day 0 during procedure
score assessed by 2 blinded evaluators during scenario
1 secondary outcome
Technical skills
Time frame: day 0 during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 28974071Neuschwander A, Job A, Younes A, Mignon A, Delgoulet C, Cabon P, Mantz J, Tesniere A. Impact of sleep deprivation on anaesthesia residents' non-technical skills: a pilot simulation-based prospective randomized trial. Br J Anaesth. 2017 Jul 1;119(1):125-131. doi: 10.1093/bja/aex155.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep deprivation in people with Sleep Deprivation, run by University of Paris 5 - Rene Descartes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetists non technical skills (ANTS) scale (time frame: day 0 during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02622217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.