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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01295749
Acronym
FLOWERS
Enrollment
84
Registered
2011-02-14
Start date
2011-03-31
Completion date
2012-06-30
Last updated
2012-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

cardiac arrest, No Flow, Emergency, Nurse, laryngeal Tube

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

Interventions

DEVICElaryngeal tube ventilation and continuous chest compression

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

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
comparison of no flow time between two strategiesarrival of paramedical staff T0group 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

MeasureTime frameDescription
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrestduring cardiac arrest at T0No flow proportion during resuscitation by paramedical staff after emergency training

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026