TeleMacc: Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage

• Sponsor: University Hospital, Rouen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01936597
• Collaborator: (none)
• Enrollment: 210
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 104.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Other: Therapeutic and preventive strategies; Other: Therapeutic and preventive strategies; Other: Therapeutic and preventive strategies	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage During Training in Non-hospital Cardiac Cases.
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single set (control Arm) method of external cardiac massage incentive based on a single set. Intervention : Therapeutic and preventive strategies	Other: Therapeutic and preventive strategies; Single set (control Arm)
Experimental: Controller Audio continuous guidance method by the controller. Intervention : Therapeutic and preventive strategies	Other: Therapeutic and preventive strategies; Controller
Experimental: Audio Audio continuous guidance method by the controller relayed by an audio. Intervention : Therapeutic and preventive strategies	Other: Therapeutic and preventive strategies; Audio

Outcome Measures

Primary Outcome Measures

1. frequency and depth of chest compressions [at the end of the simulation (10 minutes)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU - Hôptaux de Rouen (Hôpital Charles Nicolle)	Rouen		France	76031

Sponsors and Collaborators

• University Hospital, Rouen

Investigators

• Principal Investigator: Cédric DAMM, Doctor, CHU - Hôpitaux de Rouen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Rouen
• ClinicalTrials.gov Identifier: NCT01936597
• Other Study ID Numbers: 2012/182/HP; 2012-A01257-36
• First Posted: Sep 6, 2013
• Last Update Posted: Jun 19, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by University Hospital, Rouen: external cardiac massage, medical hotline,
• Additional relevant MeSH terms: Heart Arrest

Study Results

No Results Posted as of Jun 19, 2014