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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01295749
First received: February 11, 2011
Last updated: July 2, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Cardiac Arrest
Device: laryngeal tube ventilation and continuous chest compression
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Reduction of no Flow Time During Out of Hospital Cardiac Arrest by Using Laryngeal Tube for Airway Management by Nurses.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • comparison of no flow time between two strategies [ Time Frame: arrival of paramedical staff T0 ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest [ Time Frame: during cardiac arrest at T0 ] [ Designated as safety issue: No ]
    No flow proportion during resuscitation by paramedical staff after emergency training

  • qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest [ Time Frame: during cardiac arrest at T0 ] [ Designated as safety issue: No ]
    no flow proportion on total resuscitation duration

  • qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest [ Time Frame: during cardiac arrest at T0 ] [ Designated as safety issue: No ]
    number of failure installation after 2 tests

  • qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest [ Time Frame: during cardiac arrest at T0 ] [ Designated as safety issue: No ]
    Time of device installation

  • qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest [ Time Frame: during cardiac arrest at T0 ] [ Designated as safety issue: No ]
    chest expansion during insuflation (yes/no)

  • qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest [ Time Frame: during cardiac arrest at T0 ] [ Designated as safety issue: No ]
    Mortality : spontaneous cardiac activity recovery, hospital admission, reanimation service or hospital exit date, survival at 28 days , CPC evaluation for patients alive

  • qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest [ Time Frame: during cardiac arrest at T0 ] [ Designated as safety issue: No ]

    incident during ventilation :

    obstruction number of manipulations to optimize ventilation


  • qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest [ Time Frame: during cardiac arrest at T0 ] [ Designated as safety issue: No ]
    ETCO2

  • qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest [ Time Frame: during cardiac arrest at T0 ] [ Designated as safety issue: No ]
    Number of external electric shocks

  • qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest [ Time Frame: during cardiac arrest a T0 ] [ Designated as safety issue: No ]
    degradation due to technical manipulations


Enrollment: 84
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ventilation by laryngeal tube
ventilation by laryngeal tube and continuous chest compression
Device: laryngeal tube ventilation and continuous chest compression
Comparison of no flow time between two strategies in out of hospital cardiac arrest
Other Name: Laryngeal Tube LTD, VBM
Sham Comparator: ventilation by bag valve mask
ventilation by bag valve mask and interrupted chest compression
Device: laryngeal tube ventilation and continuous chest compression
Comparison of no flow time between two strategies in out of hospital cardiac arrest
Other Name: Laryngeal Tube LTD, VBM

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295749

Locations
France
SDIS
Fontaine, Isere, France, 38602
Samu Smur
Grenoble, Isere, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Vincent Danel, MD CHU Grenoble
  More Information

Additional Information:
Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01295749     History of Changes
Other Study ID Numbers: DCIC - 1014
Study First Received: February 11, 2011
Last Updated: July 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by University Hospital, Grenoble:
cardiac arrest
No Flow
Emergency
Nurse
laryngeal Tube

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014