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Out of Hospital Cardiac Arrest: Trial Assessing the Survival Impact of Phone Advice (CONTAC)

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ClinicalTrials.gov Identifier: NCT02934867
Recruitment Status : Not yet recruiting
First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Dijon
Central Hospital, Nancy, France
University Hospital, Metz
University Hospital, Strasbourg, France
University Hospital, Reims
Centre Hospitalier de Lons Le Saunier
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Centre Hospitalier de Colmar
Centre Hospitalier de Troyes
Centre Hospitalier de Chalon sur Saône
Centre Hospitalier Universitaire de Nīmes
Nantes University Hospital
University Hospital, Bordeaux
University Hospital, Lyon
Poitiers University Hospital
University Hospital, Angers
University Hospital, Orléans
Centre Hospitalier de Montauban
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
Medical call center have no phone advice protocol within out of hospital cardiac arrest in France. The purpose of the present study is to compare a group of patients with protocol phone advice delivered by the dispatchers ("CONTARM" group) versus usual phone advice ( "CONTHAB" group). Comparison will be performed on survival to seven days. The hypothesis is that CONTARM group has an higher survival at seven days. A second goal is to measure the survival to 15 and 30 days. The trial is randomized, controlled and will include 2600 patients. The patients will be enrolled in 19 hospitals in France.

Condition or disease Intervention/treatment Phase
Out of Hospital Cardiac Arrest Other: Protocol phone advice Other: Usual phone advice Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Out of Hospital Cardiac Arrest: Cluster Randomized Trial Assessing the Survival Impact of Phone Advice Delivered by Medical Call Center
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CONTARM
Protocol phone advice
Other: Protocol phone advice
Protocol phone advice

CONTHAB
Usual phone advice
Other: Usual phone advice
Usual phone advice




Primary Outcome Measures :
  1. 7 days survival [ Time Frame: 7 days ]
    7 days survival


Secondary Outcome Measures :
  1. 15 and 30 days survival [ Time Frame: 15 and 30 days ]
    15 and 30 days survival

  2. Assessment of compliance of phone advice [ Time Frame: 7 days ]

    Listening of phone bands to measure compliance of phone advice protocol :

    • good frequency of chest compression. Binary variable (Yes or Not)
    • good depth of chest compression. Binary variable (Yes or Not)
    • good patient positioning. Binary variable (Yes or No).

  3. 30 days neurological status [ Time Frame: 30 days ]
    Cerebral performance categories scale is counting with medical file



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years old
  • initial call to 15
  • out of hospital cardiac arrest
  • patient proximity to witness

Exclusion Criteria:

  • first aid professionals on site
  • rigor mortis
  • location not allowing resuscitation
  • inability to realize actions or misunderstanding
  • no flow > 5 minutes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934867


Locations
France
CHU Angers Not yet recruiting
Angers, France
Contact: Hamdan         
CHU Besançon Not yet recruiting
Besançon, France
Contact: Labourey         
CHU Bordeaux Not yet recruiting
Bordeaux, France
Contact: Pradeau         
CH Châlon sur Saône Not yet recruiting
Châlon sur Saône, France
Contact: Corrège         
CH Colmar Not yet recruiting
Colmar, France
Contact: Gottwallès         
CHU Dijon Not yet recruiting
Dijon, France
Contact: Tissier         
CH Lons Le Saunier Not yet recruiting
Lons Le Saunier, France
Contact: Duffait         
CHU Lyon Not yet recruiting
Lyon, France
Contact: Gueugniaud         
CHU Metz Not yet recruiting
Metz, France
Contact: Braun         
CH Montauban Not yet recruiting
Montauban, France
Contact: Sourbes         
CH Mulhouse Not yet recruiting
Mulhouse, France
Contact: Pernot         
CHU Nancy Not yet recruiting
Nancy, France
Contact: Nace         
CHU Nantes Not yet recruiting
Nantes, France
Contact: Jenvrin         
CHU Nîmes Not yet recruiting
Nîmes, France
Contact: Onde         
CH Orléans Not yet recruiting
Orléans, France
Contact: Bathellier         
CHU Poitiers Not yet recruiting
Poitiers, France
Contact: Marjanovic         
CHU Reims Not yet recruiting
Reims, France
Contact: Léon         
CHU Strasbourg Not yet recruiting
Strasbourg, France
Contact: Delplancq         
CH Troyes Not yet recruiting
Troyes, France
Contact: Witte         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire Dijon
Central Hospital, Nancy, France
University Hospital, Metz
University Hospital, Strasbourg, France
University Hospital, Reims
Centre Hospitalier de Lons Le Saunier
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Centre Hospitalier de Colmar
Centre Hospitalier de Troyes
Centre Hospitalier de Chalon sur Saône
Centre Hospitalier Universitaire de Nīmes
Nantes University Hospital
University Hospital, Bordeaux
University Hospital, Lyon
Poitiers University Hospital
University Hospital, Angers
University Hospital, Orléans
Centre Hospitalier de Montauban

Publications:
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02934867     History of Changes
Other Study ID Numbers: CONTAC R/2015/50
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases