Clinical trial NCT02934867: Out of Hospital Cardiac Arrest: Trial Assessing the Survival Impact of Phone Advice
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
Overall status: COMPLETED
Phase: NA
Conditions: Out of Hospital Cardiac Arrest
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dijon
name: Central Hospital, Nancy, France
name: University Hospital, Metz
name: University Hospital, Strasbourg, France
name: Reims University hospital
name: Centre Hospitalier de Lons Le Saunier
name: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
name: Centre Hospitalier de Colmar
name: Centre Hospitalier de Troyes
name: Centre Hospitalier de Chalon sur Saône
name: Centre Hospitalier Universitaire de Nīmes
name: Nantes University Hospital
name: University Hospital, Bordeaux
name: Hospices Civils de Lyon
name: Poitiers University Hospital
name: University Hospital, Angers
name: University Hospital, Orléans
name: Centre Hospitalier de Montauban
First posted: 2016-10-17
Enrollment: 729
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 7 days survival
timeFrame: 7 days
Secondary outcomes:
measure: 15 and 30 days survival
timeFrame: 15 and 30 days
measure: Assessment of compliance of phone advice
timeFrame: 7 days
measure: 30 days neurological status
timeFrame: 30 days
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Châlon sur Saône
country: France
facility: CH Châlon sur Saône
city: Colmar
country: France
facility: CH Colmar
city: Dijon
country: France
facility: CHU Dijon
city: Lons Le Saunier
country: France
facility: CH Lons Le Saunier
city: Lyon
country: France
facility: CHU Lyon
city: Metz
country: France
facility: CHU Metz
city: Montauban
country: France
facility: CH Montauban
city: Mulhouse
country: France
facility: CH Mulhouse
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Nîmes
country: France
facility: CHU Nîmes
city: Orléans
country: France
facility: CH Orléans
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: CHU Reims
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Troyes
country: France
facility: CH Troyes
Study officials:
References:
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.
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.
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.
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.
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.