Effects of Laryngeal Tube Ventilation on no Flow Time During Out of

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01295749
Study type	Interventional
Source	University Hospital, Grenoble
Contact
Status	Completed
Phase	Phase 3
Start date	March 2011
Completion date	June 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms