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

Primary Purpose

Out of Hospital Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Protocol phone advice
Usual phone advice
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out of Hospital Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU AngersRecruiting
  • CHU BesançonRecruiting
  • CHU BordeauxRecruiting
  • CH Châlon sur SaôneRecruiting
  • CH ColmarRecruiting
  • CHU DijonRecruiting
  • CH Lons Le SaunierRecruiting
  • CHU LyonRecruiting
  • CHU MetzRecruiting
  • CH MontaubanRecruiting
  • CH MulhouseRecruiting
  • CHU NancyRecruiting
  • CHU NantesRecruiting
  • CHU NîmesRecruiting
  • CH OrléansRecruiting
  • CHU PoitiersRecruiting
  • CHU ReimsRecruiting
  • CHU StrasbourgRecruiting
  • CH TroyesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CONTARM

CONTHAB

Arm Description

Protocol phone advice

Usual phone advice

Outcomes

Primary Outcome Measures

7 days survival
7 days survival

Secondary Outcome Measures

15 and 30 days survival
15 and 30 days survival
Assessment of compliance of phone advice
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).
30 days neurological status
Cerebral performance categories scale is counting with medical file

Full Information

First Posted
July 26, 2016
Last Updated
January 24, 2020
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Centre Hospitalier Universitaire Dijon, Central Hospital, Nancy, France, University Hospital, Metz, University Hospital, Strasbourg, France, Reims University Hospital, Centre Hospitalier de Lons Le Saunier, Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Hospital Center De Colmar, Centre Hospitalier de Troyes, Centre Hospitalier de Chalon sur Saône, Centre Hospitalier Universitaire de Nīmes, Nantes University Hospital, University Hospital, Bordeaux, Hospices Civils de Lyon, Poitiers University Hospital, University Hospital, Angers, University Hospital, Orléans, Centre Hospitalier de Montauban
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1. Study Identification

Unique Protocol Identification Number
NCT02934867
Brief Title
Out of Hospital Cardiac Arrest: Trial Assessing the Survival Impact of Phone Advice
Acronym
CONTAC
Official Title
Out of Hospital Cardiac Arrest: Cluster Randomized Trial Assessing the Survival Impact of Phone Advice Delivered by Medical Call Center
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2016 (undefined)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Centre Hospitalier Universitaire Dijon, Central Hospital, Nancy, France, University Hospital, Metz, University Hospital, Strasbourg, France, Reims University Hospital, Centre Hospitalier de Lons Le Saunier, Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Hospital Center De Colmar, Centre Hospitalier de Troyes, Centre Hospitalier de Chalon sur Saône, Centre Hospitalier Universitaire de Nīmes, Nantes University Hospital, University Hospital, Bordeaux, Hospices Civils de Lyon, Poitiers University Hospital, University Hospital, Angers, University Hospital, Orléans, Centre Hospitalier de Montauban

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out of Hospital Cardiac Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CONTARM
Arm Type
Experimental
Arm Description
Protocol phone advice
Arm Title
CONTHAB
Arm Type
Other
Arm Description
Usual phone advice
Intervention Type
Other
Intervention Name(s)
Protocol phone advice
Intervention Description
Protocol phone advice
Intervention Type
Other
Intervention Name(s)
Usual phone advice
Intervention Description
Usual phone advice
Primary Outcome Measure Information:
Title
7 days survival
Description
7 days survival
Time Frame
7 days
Secondary Outcome Measure Information:
Title
15 and 30 days survival
Description
15 and 30 days survival
Time Frame
15 and 30 days
Title
Assessment of compliance of phone advice
Description
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).
Time Frame
7 days
Title
30 days neurological status
Description
Cerebral performance categories scale is counting with medical file
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hamdan, MD
Phone
02 41 35 32 97
Email
hamdandavid@yahoo.fr
Facility Name
CHU Besançon
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc Labourey, MD
Phone
03 81 66 82 59
Email
jmlabourey@chu-besancon.fr
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Pradeau, MD
Email
catherine.pradeau@chu-bordeaux.fr
Facility Name
CH Châlon sur Saône
City
Châlon sur Saône
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Corrège, MD
Phone
03 85 91 00 76
Email
david.corege@ch-chalon71.fr
Facility Name
CH Colmar
City
Colmar
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannick Gottwallès, MD
Phone
03 89 12 40 96
Email
yannick.gottwalles@ch-colmar.fr
Facility Name
CHU Dijon
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cindy Tissier, MD
Phone
03 80 29 51 12
Email
cindy.tissier@chu-dijon.fr
Facility Name
CH Lons Le Saunier
City
Lons Le Saunier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves Duffait, MD
Phone
03 84 35 60 03
Email
yvesgaelle@hotmail.com
Facility Name
CHU Lyon
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Yves Gueugniaud, MD
Phone
04 72 11 00 41
Email
pierre-yves.gueugniaud@chu-lyon.fr
Facility Name
CHU Metz
City
Metz
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Braun, MD
Phone
03 87 55 92 92
Email
fr.braun@chr-metz-thionville.fr
Facility Name
CH Montauban
City
Montauban
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeline Sourbes, MD
Phone
05 63 92 81 51
Email
a.sourbes@ch-montauban.fr
Facility Name
CH Mulhouse
City
Mulhouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Pernot, MD
Phone
03 89 64 62 72
Email
pernotf@ch-mulhouse.fr
Facility Name
CHU Nancy
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Nace, MD
Phone
03 83 85 14 96
Email
l.nace@chru-nancy.fr
Facility Name
CHU Nantes
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Jenvrin, MD
Phone
05 56 79 56 79
Email
catherine.pradeau@chu-bordeaux.fr
Facility Name
CHU Nîmes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Onde, MD
Phone
04 66 68 37 08
Email
olivier.onde@chu-nimes.fr
Facility Name
CH Orléans
City
Orléans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Narcisse, MD
Phone
02 38 22 98 54
Email
sophie.narcisse@chr-orleans.fr
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Marjanovic, MD
Phone
05 49 44 44 88
Email
nicolasmarjanivic@free.fr
Facility Name
CHU Reims
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Léon, MD, PhD
Phone
03 26 78 70 30
Email
aleon@chu-reims.fr
Facility Name
CHU Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé Delplancq, MD
Phone
03 69 55 31 42
Email
herve.delplancq@chru-strasbourg.fr
Facility Name
CH Troyes
City
Troyes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Malbranque, MD
Phone
03.25.49.49.49
Email
arnaud.malbranque@ch-troyes.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
20956221
Citation
Berg RA, Hemphill R, Abella BS, Aufderheide TP, Cave DM, Hazinski MF, Lerner EB, Rea TD, Sayre MR, Swor RA. Part 5: adult basic life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S685-705. doi: 10.1161/CIRCULATIONAHA.110.970939. Erratum In: Circulation. 2011 Oct 11;124(15):e402.
Results Reference
background
PubMed Identifier
20956052
Citation
Nolan JP, Soar J, Zideman DA, Biarent D, Bossaert LL, Deakin C, Koster RW, Wyllie J, Bottiger B; ERC Guidelines Writing Group. European Resuscitation Council Guidelines for Resuscitation 2010 Section 1. Executive summary. Resuscitation. 2010 Oct;81(10):1219-76. doi: 10.1016/j.resuscitation.2010.08.021. No abstract available.
Results Reference
background
PubMed Identifier
20956051
Citation
Koster RW, Baubin MA, Bossaert LL, Caballero A, Cassan P, Castren M, Granja C, Handley AJ, Monsieurs KG, Perkins GD, Raffay V, Sandroni C. European Resuscitation Council Guidelines for Resuscitation 2010 Section 2. Adult basic life support and use of automated external defibrillators. Resuscitation. 2010 Oct;81(10):1277-92. doi: 10.1016/j.resuscitation.2010.08.009. No abstract available.
Results Reference
background
Citation
Desmettre T, Jenvrin J, Freysz M, Nace L, Puyraveau M, Berthier F, Dreyfus P, Philippe MH, Labourey JM, Capellier G. Drug prescription at the medical call center. Ann. Fr. Med. Urgence (2013) 3:14-19.
Results Reference
background
Citation
Sigaux A, Jonquet S, Puyraveau M, Bretillot L, Labourey JM, Capellier G, Desmettre T. Evaluation of phone advice delivered by a medical call center in case of cardiac arrest. Ann. Fr. Med. Urgence (2014) 4:11-17.
Results Reference
background

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

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