CONTAC: Out of Hospital Cardiac Arrest: Trial Assessing the Survival Impact of Phone Advice
Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Unknown status
CT.gov ID
NCT02934867
Collaborator
Centre Hospitalier Universitaire Dijon (Other), Central Hospital, Nancy, France (Other), University Hospital, Metz (Other), University Hospital, Strasbourg, France (Other), Reims University Hospital (Other), Centre Hospitalier de Lons Le Saunier (Other), Groupe Hospitalier de la Region de Mulhouse et Sud Alsace (Other), Hospital Center De Colmar (Other), Centre Hospitalier de Troyes (Other), Centre Hospitalier de Chalon sur Saône (Other), Centre Hospitalier Universitaire de Nīmes (Other), Nantes University Hospital (Other), University Hospital, Bordeaux (Other), Hospices Civils de Lyon (Other), Poitiers University Hospital (Other), University Hospital, Angers (Other), University Hospital, Orléans (Other), Centre Hospitalier de Montauban (Other)
2,600
19
2
55
136.8
2.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated 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
:
Sep 1, 2016
Anticipated Primary Completion Date
:
Nov 1, 2020
Anticipated Study Completion Date
:
Apr 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CONTARM Protocol phone advice |
Other: Protocol phone advice
Protocol phone advice
|
| Other: CONTHAB Usual phone advice |
Other: Usual phone advice
Usual phone advice
|
Outcome Measures
Primary Outcome Measures
- 7 days survival [7 days]
7 days survival
Secondary Outcome Measures
- 15 and 30 days survival [15 and 30 days]
15 and 30 days survival
- Assessment of compliance of phone advice [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).
- 30 days neurological status [30 days]
Cerebral performance categories scale is counting with medical file
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Angers | Angers | France | ||
| 2 | CHU Besançon | Besançon | France | ||
| 3 | CHU Bordeaux | Bordeaux | France | ||
| 4 | CH Châlon sur Saône | Châlon sur Saône | France | ||
| 5 | CH Colmar | Colmar | France | ||
| 6 | CHU Dijon | Dijon | France | ||
| 7 | CH Lons Le Saunier | Lons Le Saunier | France | ||
| 8 | CHU Lyon | Lyon | France | ||
| 9 | CHU Metz | Metz | France | ||
| 10 | CH Montauban | Montauban | France | ||
| 11 | CH Mulhouse | Mulhouse | France | ||
| 12 | CHU Nancy | Nancy | France | ||
| 13 | CHU Nantes | Nantes | France | ||
| 14 | CHU Nîmes | Nîmes | France | ||
| 15 | CH Orléans | Orléans | France | ||
| 16 | CHU Poitiers | Poitiers | France | ||
| 17 | CHU Reims | Reims | France | ||
| 18 | CHU Strasbourg | Strasbourg | France | ||
| 19 | CH Troyes | Troyes | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
- 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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review. Erratum in: Circulation. 2011 Oct 11;124(15):e402.
- 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.
- Koster RW, Baubin MA, Bossaert LL, Caballero A, Cassan P, Castrén 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.
- Nolan JP, Soar J, Zideman DA, Biarent D, Bossaert LL, Deakin C, Koster RW, Wyllie J, Böttiger 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.
- 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.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT02934867
Other Study ID Numbers:
- CONTAC R/2015/50
First Posted:
Oct 17, 2016
Last Update Posted:
Jan 27, 2020
Last Verified:
Jan 1, 2020