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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 3

Conditions: Cardiac Arrest

Treatments: Device: laryngeal tube ventilation and continuous chest compression

Study type: Interventional

Funder types: Other

Identifiers

NCT01295749

DCIC - 1014

Details and patient eligibility

About

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.

Full 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

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

ventilation by laryngeal tube

Active Comparator group

Description:

ventilation by laryngeal tube and continuous chest compression

Treatment:

Device: laryngeal tube ventilation and continuous chest compression

Device: laryngeal tube ventilation and continuous chest compression

ventilation by bag valve mask

Sham Comparator group

Description:

ventilation by bag valve mask and interrupted chest compression

Treatment:

Device: laryngeal tube ventilation and continuous chest compression

Device: laryngeal tube ventilation and continuous chest compression