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

Assistance Publique - Hôpitaux de Paris2,043 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,043

Conditions

Out-of-hospital Cardiac Arrest

Interventions

bag-valve-mask ventilationPROCEDURE

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.

tracheal intubationPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Avicenne Hospital - Aphp

Bobigny, Île-de-France Region, France

Outcomes

Primary Outcomes

Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less.

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

Time frame: Day 28

Secondary Outcomes

Survival at hospital admission

Time frame: Day 0

Survival

Time frame: Day 28

Survival at hospital discharge

Time frame: up to Day 28

Neurologic outcomes assessed by modified Rankin scale score

Time frame: Day 28

Rate of return of spontaneous circulation (ROSC)

Time frame: Day 0

Intubation difficulty assessed by Intubation difficulty Scale score

Time frame: Day 0

Complications related to tracheal intubation

Complications related to tracheal intubation during advanced Cardiopulmonary Resuscitation (CPR): failure, esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, extubation

Time frame: Day 0

Complications related to bag-valve-mask ventilation

Complications related to bag-valve-mask ventilation during advanced CPR: regurgitation of gastric content

Data from ClinicalTrials.gov

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