Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest

Phase 3

Completed

• Conditions: Cardiac Arrest
• Interventions: Device: laryngeal tube ventilation and continuous chest compression

• Registration Number: NCT01295749
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

International recommendations stress on the importance of no flow time reduction in cardiac arrest management. In fact, no flow time is an independent factor of morbidity and mortality.

In France, cardiac arrests are treated by first responders (including emergency nurses) before the arrival of a mobile intensive care unit. Those first responders use bag-valve-mask for ventilation and therefore practice conventional CPR (30 chest compression / 2 ventilation rhythm). Laryngeal tube is a safe and efficient device in cardiac arrest ventilation. The purpose of our study is to compare the no flow time between two strategies of out of hospital cardiac arrest management by first responders: conventional CPR with bag-valve-mask ventilation vs. compression only CPR with Laryngeal Tube ventilation.

Detailed Description

Multicentric, prospective, controlled, randomized study with parallel groups in single blind.

Patients will be included in chronological periods to avoid selection biais (one month with the first medical device the next month with the other one). The determination of these periods will be centralized. The emergency vehicles will be supplied sufficiently with devices. This design has been chosen in order to answer to the emergency problem.

Patients will be included and ventilated by paramedical staff (first responders) before medical staff (Mobile Intensive Care Unit) intervention. Complete detailed information will be given to the patient or to the family and consent asked.

The comparison of no flow time between the two strategies in out of hospital cardiac arrest will be the following :

A : ventilation by bag valve mask and interrupted chest compression B : ventilation by laryngeal tube and continuous chest compression

Study Timeline

• Study First Submitted: 2011-02-11
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Study Start: 2011-03
• Primary Completion: 2012-02
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-02
• Last Update Posted: 2012-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• preliminary treatment of cardiac arrest by fire fighters (Basic Life support)
• more than 18 years
• patient affiliated to the social security system or equivalent

Exclusion Criteria

• certain death
• patient deprived of freedom by judicial or administrative decision
• patient under legal protection
• Pregnancy, parturient or breast feeding
• facial trauma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ventilation by bag valve mask	laryngeal tube ventilation and continuous chest compression	ventilation by bag valve mask and interrupted chest compression
ventilation by laryngeal tube	laryngeal tube ventilation and continuous chest compression	ventilation by laryngeal tube and continuous chest compression

Primary Outcome Measures

Name	Time	Method
comparison of no flow time between two strategies	arrival of paramedical staff T0	group A : ventilation by bag valve mask and interrupted chest compression group B : ventilation by laryngeal tube and continuous chest compression; outcome measure : time of no flow during Resuscitation by trained paramedical staff in out of hospital cardiac arrest

Secondary Outcome Measures

Name	Time	Method
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	during cardiac arrest a T0	degradation due to technical manipulations

Trial Locations

Locations (2)

Samu Smur; 🇫🇷 Grenoble, Isere, France

SDIS; 🇫🇷 Fontaine, Isere, France