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Completed

NCT Number: NCT01295749

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

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Disease Attributes Emergencies Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SDIS, Fontaine, Isere, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laryngeal tube ventilation and continuous chest compression

Device

Comparison of no flow time between two strategies in out of hospital cardiac arrest

Other names: Laryngeal Tube LTD, VBM

Primary outcomes

  1. comparison of no flow time between two strategies

    Time frame: 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 outcomes

  1. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    Time frame: during cardiac arrest at T0

    No flow proportion during resuscitation by paramedical staff after emergency training

  2. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    Time frame: during cardiac arrest at T0

    no flow proportion on total resuscitation duration

  3. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    Time frame: during cardiac arrest at T0

    number of failure installation after 2 tests

  4. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    Time frame: during cardiac arrest at T0

    Time of device installation

  5. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    Time frame: during cardiac arrest at T0

    chest expansion during insuflation (yes/no)

  6. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    Time frame: during cardiac arrest at T0

    Mortality : spontaneous cardiac activity recovery, hospital admission, reanimation service or hospital exit date, survival at 28 days , CPC evaluation for patients alive

  7. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    Time frame: during cardiac arrest at T0

    incident during ventilation :

    obstruction number of manipulations to optimize ventilation

  8. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    Time frame: during cardiac arrest at T0

    ETCO2

  9. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    Time frame: during cardiac arrest at T0

    Number of external electric shocks

  10. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    Time frame: during cardiac arrest a T0

    degradation due to technical manipulations

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: FLOWERS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 14, 2011
Registry last updated
Jul 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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