NCT02934867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
729

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2021

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2020

Enrollment Period

5 years

First QC Date

July 26, 2016

Last Update Submit

January 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 7 days survival

    7 days survival

    7 days

Secondary Outcomes (3)

  • 15 and 30 days survival

    15 and 30 days

  • Assessment of compliance of phone advice

    7 days

  • 30 days neurological status

    30 days

Study Arms (2)

CONTARM

EXPERIMENTAL

Protocol phone advice

Other: Protocol phone advice

CONTHAB

OTHER

Usual phone advice

Other: Usual phone advice

Interventions

Protocol phone advice

CONTARM

Usual phone advice

CONTHAB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

CHU Angers

Angers, France

Location

CHU Besançon

Besançon, France

Location

CHU Bordeaux

Bordeaux, France

Location

CH Châlon sur Saône

Châlon Sur Saône, France

Location

CH Colmar

Colmar, France

Location

CHU Dijon

Dijon, France

Location

CH Lons Le Saunier

Lons-le-Saunier, France

Location

CHU Lyon

Lyon, France

Location

CHU Metz

Metz, France

Location

CH Montauban

Montauban, France

Location

CH Mulhouse

Mulhouse, France

Location

CHU Nancy

Nancy, France

Location

CHU Nantes

Nantes, France

Location

CHU Nîmes

Nîmes, France

Location

CH Orléans

Orléans, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Reims

Reims, France

Location

CHU Strasbourg

Strasbourg, France

Location

CH Troyes

Troyes, France

Location

Related 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.

    PMID: 20956221BACKGROUND
  • 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.

    PMID: 20956052BACKGROUND
  • 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.

    PMID: 20956051BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

October 17, 2016

Study Start

October 12, 2016

Primary Completion

October 12, 2021

Study Completion

October 19, 2021

Last Updated

January 16, 2025

Record last verified: 2020-01

Locations