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

Out of Hospital Cardiac Arrest Clinical Trial

— CONTAC  

Official title:

Out of Hospital Cardiac Arrest: Cluster Randomized Trial Assessing the Survival Impact of Phone Advice Delivered by Medical Call Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02934867
• Other study ID #: CONTAC R/2015/50
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: April 1, 2021

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2600
• Est. completion date: April 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out of Hospital Cardiac Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• Protocol phone advice
Protocol phone advice
• Usual phone advice
Usual phone advice

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Besançon	Besançon
France	CHU Bordeaux	Bordeaux
France	CH Châlon sur Saône	Châlon sur Saône
France	CH Colmar	Colmar
France	CHU Dijon	Dijon
France	CH Lons Le Saunier	Lons Le Saunier
France	CHU Lyon	Lyon
France	CHU Metz	Metz
France	CH Montauban	Montauban
France	CH Mulhouse	Mulhouse
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	CHU Nîmes	Nîmes
France	CH Orléans	Orléans
France	CHU Poitiers	Poitiers
France	CHU Reims	Reims
France	CHU Strasbourg	Strasbourg
France	CH Troyes	Troyes

Sponsors (19)

Lead Sponsor

Collaborator

Centre Hospitalier Universitaire de Besancon

Central Hospital, Nancy, France, Centre Hospitalier de Chalon sur Saône, Centre Hospitalier de Lons Le Saunier, Centre Hospitalier de Montauban, Centre Hospitalier de Troyes, Centre Hospitalier Universitaire de Nimes, Centre Hospitalier Universitaire Dijon, Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Hospital Center De Colmar, Nantes University Hospital, Poitiers University Hospital, Reims University Hospital, University Hospital, Angers, University Hospital, Bordeaux, University Hospital, Lyon, University Hospital, Metz, University Hospital, Orléans, University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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.

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. — View Citation

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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7 days survival	7 days survival	7 days
Secondary	15 and 30 days survival	15 and 30 days survival	15 and 30 days
Secondary	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).	7 days
Secondary	30 days neurological status	Cerebral performance categories scale is counting with medical file	30 days