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

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
laryngeal tube ventilation and continuous chest compression
laryngeal tube ventilation and continuous chest compression
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiac Arrest focused on measuring cardiac arrest, No Flow, Emergency, Nurse, laryngeal Tube

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SDIS
  • Samu Smur

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ventilation by laryngeal tube

ventilation by bag valve mask

Arm Description

ventilation by laryngeal tube and continuous chest compression

ventilation by bag valve mask and interrupted chest compression

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
No flow proportion during resuscitation by paramedical staff after emergency training
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
no flow proportion on total resuscitation duration
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
number of failure installation after 2 tests
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Time of device installation
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
chest expansion during insuflation (yes/no)
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
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
incident during ventilation : obstruction number of manipulations to optimize ventilation
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
ETCO2
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Number of external electric shocks
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
degradation due to technical manipulations

Full Information

First Posted
February 11, 2011
Last Updated
July 2, 2012
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01295749
Brief Title
Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest
Acronym
FLOWERS
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, No Flow, Emergency, Nurse, laryngeal Tube

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ventilation by laryngeal tube
Arm Type
Active Comparator
Arm Description
ventilation by laryngeal tube and continuous chest compression
Arm Title
ventilation by bag valve mask
Arm Type
Sham Comparator
Arm Description
ventilation by bag valve mask and interrupted chest compression
Intervention Type
Device
Intervention Name(s)
laryngeal tube ventilation and continuous chest compression
Other Intervention Name(s)
Laryngeal Tube LTD, VBM
Intervention Description
Comparison of no flow time between two strategies in out of hospital cardiac arrest
Intervention Type
Device
Intervention Name(s)
laryngeal tube ventilation and continuous chest compression
Other Intervention Name(s)
Laryngeal Tube LTD, VBM
Intervention Description
Comparison of no flow time between two strategies in out of hospital cardiac arrest
Primary Outcome Measure Information:
Title
comparison of no flow time between two strategies
Description
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
Time Frame
arrival of paramedical staff T0
Secondary Outcome Measure Information:
Title
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Description
No flow proportion during resuscitation by paramedical staff after emergency training
Time Frame
during cardiac arrest at T0
Title
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Description
no flow proportion on total resuscitation duration
Time Frame
during cardiac arrest at T0
Title
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Description
number of failure installation after 2 tests
Time Frame
during cardiac arrest at T0
Title
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Description
Time of device installation
Time Frame
during cardiac arrest at T0
Title
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Description
chest expansion during insuflation (yes/no)
Time Frame
during cardiac arrest at T0
Title
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Description
Mortality : spontaneous cardiac activity recovery, hospital admission, reanimation service or hospital exit date, survival at 28 days , CPC evaluation for patients alive
Time Frame
during cardiac arrest at T0
Title
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Description
incident during ventilation : obstruction number of manipulations to optimize ventilation
Time Frame
during cardiac arrest at T0
Title
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Description
ETCO2
Time Frame
during cardiac arrest at T0
Title
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Description
Number of external electric shocks
Time Frame
during cardiac arrest at T0
Title
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Description
degradation due to technical manipulations
Time Frame
during cardiac arrest a T0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Danel, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
SDIS
City
Fontaine
State/Province
Isere
ZIP/Postal Code
38602
Country
France
Facility Name
Samu Smur
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

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

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