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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02123810
Other study ID # BG-CAN
Secondary ID
Status Completed
Phase N/A
First received April 22, 2014
Last updated July 20, 2015
Start date April 2014
Est. completion date October 2014

Study information

Verified date July 2015
Source Bistro Study Group
Contact n/a
Is FDA regulated No
Health authority France: Conseil National de l'Ordre des Médecins
Study type Interventional

Clinical Trial Summary

The investigators sought to evaluate the influence of fatigue after a night shift on the quality of Chest Compressions (CC) in CardioPulmonary Resuscitation (CPR), among physicians.


Description:

This is a non inferiority cluster randomized trial on three Emergency Departments (ED) and five Intensive Care Unit (ICU) from three urban academic hospital in Paris, France. The investigators evaluated the quality of CC with a low-fidelity manikin and its electronic feedback device. The investigators tested subjects on a 6-minutes CC-only CPR scenario, including 2 minutes of pause. Physicians were tested either on a control day then after a night shift, or after a night shift then on a control day.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date October 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Resident / Physicians in emergency departement (ED) or taking night in ED

- Resident / Physicians in Intensive Care Unit (ICU) or taking night in ED

- Nightshift > 18 hours

Exclusion Criteria:

- Stop chest compressions before 2 minutes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
CPR
Simulated cardiac arrest on a manikin Chest Compression CPR for 6 minutes

Locations

Country Name City State
France Hôpital Pitié-Salpêtrière; Hopital Saint Antoine; Hopital Tenon Paris

Sponsors (1)

Lead Sponsor Collaborator
Bistro Study Group

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Factors associated with better chest compressions (CC) The investigators assessed factors associated with better chest compressions as : age, sex and fatigue of physician and intensity of the nightshift. 2 minutes Yes
Primary the proportion of CC with a depth higher than 50mm The investigators evaluated the quality of CC with a low-fidelity manikin and its electronic feedback device. 2 minutes of chest compressions Yes
Secondary Number of chest compressions The investigators evaluated the quality of CC with a low-fidelity manikin and its electronic feedback device. 2 minutes Yes
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