NCT01936597

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

June 19, 2014

Status Verified

June 1, 2014

Enrollment Period

Same day

First QC Date

September 2, 2013

Last Update Submit

June 18, 2014

Conditions

Cardiac Arrest

Keywords

external cardiac massage, medical hotline,

Outcome Measures

Primary Outcomes (1)

  • frequency and depth of chest compressions

    at the end of the simulation (10 minutes)

Study Arms (3)

Single set (control Arm)

ACTIVE COMPARATOR

method of external cardiac massage incentive based on a single set. Intervention : Therapeutic and preventive strategies

Other: Therapeutic and preventive strategies

Controller

EXPERIMENTAL

Audio continuous guidance method by the controller. Intervention : Therapeutic and preventive strategies

Other: Therapeutic and preventive strategies

Audio

EXPERIMENTAL

Audio continuous guidance method by the controller relayed by an audio. Intervention : Therapeutic and preventive strategies

Other: Therapeutic and preventive strategies

Interventions

Therapeutic and preventive strategiesOTHER

Single set (control Arm)

Single set (control Arm)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • major physical disability;
  • do not speak French
  • first aid training under one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU - Hôptaux de Rouen (Hôpital Charles Nicolle)

Rouen, 76031, France

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Cédric DAMM, Doctor

    CHU - Hôpitaux de Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2013

First Posted

September 6, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2013

Study Completion

November 1, 2013

Last Updated

June 19, 2014

Record last verified: 2014-06

Locations

FR(1)