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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01936597
Other study ID # 2012/182/HP
Secondary ID 2012-A01257-36
Status Completed
Phase N/A
First received September 2, 2013
Last updated June 18, 2014
Start date September 2013
Est. completion date November 2013

Study information

Verified date June 2014
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

This study must evaluate the benefit of a continuous audio guidance on the effectiveness of MCE directed by a volunteer.

The evaluation of the MCE for this study is based on both quantitative criteria (based on the recommendations ERC 2010)

- frequency

- depth of chest compressions.

This study compares two methods of continuous audio guide (one arm with an audio continuous guidance method by the regulator and second arm with an audio continuous guidance method by the controller relayed by an audio) to a method of incentive MCE based on a unique set made by the regulator(control arm).


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date November 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Healthy volunteers from the general population understanding the French language.

Exclusion Criteria:

- major physical disability;

- do not speak French

- first aid training under one year

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Therapeutic and preventive strategies
Single set (control Arm)
Therapeutic and preventive strategies
Controller
Therapeutic and preventive strategies
Audio

Locations

Country Name City State
France CHU - Hôptaux de Rouen (Hôpital Charles Nicolle) Rouen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary frequency and depth of chest compressions at the end of the simulation (10 minutes) Yes
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