Tracheal Intubation vs. Bag-valve-mask Ventilation in Patients With Out-of-Hospital Cardiac Arrest _ CAAM STUDY

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Out-of-hospital Cardiac Arrest

Treatments: Procedure: tracheal intubation; Procedure: bag-valve-mask ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT02327026

2014-A01109-38 (Other Identifier)

P130932

Details and patient eligibility

About

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

Full description

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.

Enrollment: 2,043 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,043 participants in 2 patient groups

bag-valve-mask ventilation

Experimental group

Description:

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

Treatment:

Procedure: bag-valve-mask ventilation

tracheal intubation

Active Comparator group

Description:

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.

Treatment:

Procedure: tracheal intubation