Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest (FLOWERS)
2 juillet 2012 mis à jour par: University Hospital, Grenoble
Reduction of no Flow Time During Out of Hospital Cardiac Arrest by Using Laryngeal Tube for Airway Management by Nurses.
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Interventionnel
Inscription (Réel)
84
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Isere
-
Fontaine, Isere, France, 38602
- SDIS
-
Grenoble, Isere, France, 38043
- Samu Smur
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: ventilation by laryngeal tube
ventilation by laryngeal tube and continuous chest compression
|
Comparison of no flow time between two strategies in out of hospital cardiac arrest
Autres noms:
|
|
Comparateur factice: ventilation by bag valve mask
ventilation by bag valve mask and interrupted chest compression
|
Comparison of no flow time between two strategies in out of hospital cardiac arrest
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
comparison of no flow time between two strategies
Délai: 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 |
arrival of paramedical staff T0
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Délai: during cardiac arrest at T0
|
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
Délai: during cardiac arrest at T0
|
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
Délai: during cardiac arrest at T0
|
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
Délai: during cardiac arrest at T0
|
Time of device installation
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Délai: during cardiac arrest at T0
|
chest expansion during insuflation (yes/no)
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Délai: 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
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Délai: during cardiac arrest at T0
|
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
Délai: during cardiac arrest at T0
|
ETCO2
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Délai: during cardiac arrest at T0
|
Number of external electric shocks
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Délai: during cardiac arrest a T0
|
degradation due to technical manipulations
|
during cardiac arrest a T0
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Vincent Danel, MD, University Hospital, Grenoble
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2011
Achèvement primaire (Réel)
1 février 2012
Achèvement de l'étude (Réel)
1 juin 2012
Dates d'inscription aux études
Première soumission
11 février 2011
Première soumission répondant aux critères de contrôle qualité
11 février 2011
Première publication (Estimation)
14 février 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
3 juillet 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 juillet 2012
Dernière vérification
1 juillet 2012
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DCIC - 1014
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