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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02622217
Other study ID # UParis5
Secondary ID
Status Completed
Phase N/A
First received November 28, 2015
Last updated May 10, 2016
Start date January 2015
Est. completion date January 2016

Study information

Verified date May 2016
Source University of Paris 5 - Rene Descartes
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of Personnes
Study type Interventional

Clinical 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. 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2016
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Anesthesiology residents from Paris academic hospitals

Exclusion Criteria:

- Chronic sleep disorder

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep deprivation


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Paris 5 - Rene Descartes

Outcome

Type Measure Description Time frame Safety issue
Primary Anesthetists non technical skills (ANTS) scale score assessed by 2 blinded evaluators during scenario day 0 during procedure No
Secondary Technical skills Check list of items, assessed by 2 blinded evaluators during scenario day 0 during procedure No
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