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

Study Overview
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Brief Summary
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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
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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

Official Title
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Reduction of no Flow Time During Out of Hospital Cardiac Arrest by Using Laryngeal Tube for Airway Management by Nurses.

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: laryngeal tube ventilation and continuous chest compression
* Device: laryngeal tube ventilation and continuous chest compression


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ventilation by laryngeal tube<br>ventilation by laryngeal tube and continuous chest compression | Device: laryngeal tube ventilation and continuous chest compression<br>* Comparison of no flow time between two strategies in out of hospital cardiac arrest<br>* Other names: Laryngeal Tube LTD, VBM;|
| Sham Comparator: ventilation by bag valve mask<br>ventilation by bag valve mask and interrupted chest compression | Device: laryngeal tube ventilation and continuous chest compression<br>* Comparison of no flow time between two strategies in out of hospital cardiac arrest<br>* Other names: Laryngeal Tube LTD, VBM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of no flow time between two strategies | 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 | arrival of paramedical staff T0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest | No flow proportion during resuscitation by paramedical staff after emergency training | during cardiac arrest at T0 | 
| qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest | no flow proportion on total resuscitation duration | during cardiac arrest at T0 | 
| qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest | number of failure installation after 2 tests | during cardiac arrest at T0 | 
| qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest | Time of device installation | during cardiac arrest at T0 | 
| qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest | chest expansion during insuflation (yes/no) | during cardiac arrest at T0 | 
| qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest | Mortality : spontaneous cardiac activity recovery, hospital admission, reanimation service or hospital exit date, survival at 28 days , CPC evaluation for patients alive | during cardiac arrest at T0 | 
| qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest | incident during ventilation : obstruction number of manipulations to optimize ventilation | during cardiac arrest at T0 | 
| qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest | ETCO2 | during cardiac arrest at T0 | 
| qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest | Number of external electric shocks | during cardiac arrest at T0 | 
| qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest | degradation due to technical manipulations | during cardiac arrest a T0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrest, No Flow, Emergency, Nurse, laryngeal Tube