Clinical trial NCT01295749: Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest
Official title: Reduction of no Flow Time During Out of Hospital Cardiac Arrest by Using Laryngeal Tube for Airway Management by Nurses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Arrest
Keywords: cardiac arrest
No Flow
Emergency
Nurse
laryngeal Tube
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: comparison of no flow time between two strategies
timeFrame: arrival of paramedical staff T0
Secondary outcomes:
measure: qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
timeFrame: during cardiac arrest at T0
measure: qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
timeFrame: during cardiac arrest at T0
measure: qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
timeFrame: during cardiac arrest at T0
measure: qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
timeFrame: during cardiac arrest at T0
measure: qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
timeFrame: during cardiac arrest at T0
measure: qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
timeFrame: during cardiac arrest at T0
measure: qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
timeFrame: during cardiac arrest at T0
measure: qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
timeFrame: during cardiac arrest at T0
measure: qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
timeFrame: during cardiac arrest at T0
measure: qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
timeFrame: during cardiac arrest a T0
Other outcomes:
Locations:
city: Fontaine
country: France
facility: SDIS
state: Isere
city: Grenoble
country: France
facility: Samu Smur
state: Isere
Study officials:
affiliation: University Hospital, Grenoble
name: Vincent Danel, MD
role: PRINCIPAL_INVESTIGATOR
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