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- Registre américain des essais cliniques
- Essai clinique NCT02327026
Tracheal Intubation vs. Bag-valve-mask Ventilation in Patients With Out-of-Hospital Cardiac Arrest _ CAAM STUDY (CAAM)
Initial Airway Management in Patients With Out-of-Hospital Cardiac Arrest: Tracheal Intubation vs. Bag-valve-mask Ventilation - CAAM STUDY
The aim of this study is to improve the management of patients in cardiac arrest, and this by comparing two initial airway management methods: Tracheal intubation and bag-valve-mask ventilation.
The survival rate at 28-day with favorable neurological function will be compared in the tracheal intubation group versus the bag-valve-mask group
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
It is a multicenter prospective non-inferiority open randomized controlled trial in patients with out-of-hospital cardiac arrest carried out in physician-staffed emergency medical services.
The investigators hypothesis is that basic airway management (i.e. bag-valve-mask ventilation) is safe and may avoid the deleterious effects of tracheal intubation including interruption of chest compressions.
On medical team's arrival at the scene and after verification of participant's eligibility, patients will be enrolled in the study and randomly assigned to either initial bag-valve-mask ventilation or tracheal intubation. After the hospital admission, all patients will be intubated whatever the initial airway management.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Ile de France
-
Bobigny, Ile de France, France, 93000
- Avicenne Hospital - Aphp
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 18 years or older;
- Patient with out-of-hospital cardiac arrest on medical team's arrival
- Resuscitation attempted
- Medical insurance
Exclusion Criteria:
- Massive suspected aspiration
- Presence of do-not-resuscitate order
- Pregnancy
- Prisoners
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: bag-valve-mask ventilation
Airway management including initial bag-valve-mask ventilation by the medical team during OHCA.
When standard bag-valve-mask ventilation is possible, the patient will be intubated in case of a return of spontaneous circulation.
When standard bag-valve-mask ventilation is impossible or in case of massive regurgitation of gastric content (after randomisation), intubation of patient is the preferred alternative
|
Airway management including initial bag-valve-mask ventilation by the medical team during OHCA.
When standard bag-valve-mask ventilation is possible, the patient will be intubated in case of a return of spontaneous circulation.
When standard bag-valve-mask ventilation is impossible or in case of massive regurgitation of gastric content (after randomisation), intubation of patient is the preferred alternative.
|
Comparateur actif: tracheal intubation
Tracheal intubation during OHCA by the medical team: The standard intubation procedure is to use a non-styletted tube and no sedation.
When standard laryngoscopy-assisted intubation is not possible, an alternate procedure will be used based on the French consensus conference guidelines on difficult airway management.
|
Tracheal intubation during OHCA by the medical team: The standard intubation procedure is to use a non-styletted tube and no sedation.
When standard laryngoscopy-assisted intubation is not possible, an alternate procedure will be used based on the French consensus conference guidelines on difficult airway management
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less.
Délai: Day 28
|
Survival at 28-day with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less.
In case of neurological disability before randomization, the survival associated the same degree of disability will be considered a favorable neurological function
|
Day 28
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Survival at hospital admission
Délai: Day 0
|
Day 0
|
|
Survival
Délai: Day 28
|
Day 28
|
|
Survival at hospital discharge
Délai: up to Day 28
|
up to Day 28
|
|
Neurologic outcomes assessed by modified Rankin scale score
Délai: Day 28
|
Day 28
|
|
Rate of return of spontaneous circulation (ROSC)
Délai: Day 0
|
Day 0
|
|
Intubation difficulty assessed by Intubation difficulty Scale score
Délai: Day 0
|
Day 0
|
|
Complications related to tracheal intubation
Délai: Day 0
|
Complications related to tracheal intubation during advanced Cardiopulmonary Resuscitation (CPR): failure, esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, extubation
|
Day 0
|
Complications related to bag-valve-mask ventilation
Délai: Day 0
|
Complications related to bag-valve-mask ventilation during advanced CPR: regurgitation of gastric content
|
Day 0
|
Technique's failure defined as mortality
Délai: Day 0, Day 28
|
Technique's failure defined as mortality at 28-day or regurgitation during the procedure or failure of the procedure (failure to ventilate in the bag-valve-mask ventilation or failure to intubate in the intubation group)
|
Day 0, Day 28
|
Ventilation difficulty with bag-valve-mask measured with a visual-analog-scale (VAS)
Délai: Day 0
|
Day 0
|
|
Han's mask ventilation classification
Délai: Day 0
|
Day 0
|
|
Difficult mask ventilation signs
Délai: Day 0
|
Day 0
|
|
Time to completion of tracheal intubation (TI) procedure
Délai: Day 0
|
Time to completion of tracheal intubation (TI) procedure measured from the instant that the laryngoscope blade touches the patient to the moment that the tracheal tube cuff is inflated
|
Day 0
|
Duration of the interruption of chest compression during TI procedure
Délai: Day 0
|
Duration of the interruption of chest compression during TI procedure
|
Day 0
|
Duration of the interruption of chest compression during advanced CPR (from medical team's arrival to decision to stop CPR)
Délai: Day 0
|
Duration of the interruption of chest compression during advanced CPR (from medical team's arrival to decision to stop CPR)
|
Day 0
|
Duration of advanced CPR
Délai: Day 0
|
Duration of advanced CPR (from medical team's arrival to decision to stop CPR)
|
Day 0
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Frédéric Adnet, MD, PhD, Assistance Publique - Hôpitaux de Paris
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P130932
- 2014-A01109-38 (Autre identifiant: IDRCB)
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