Clinical trial NCT02327026: Tracheal Intubation vs. Bag-valve-mask Ventilation in Patients With Out-of-Hospital Cardiac Arrest _ CAAM STUDY
Official title: Initial Airway Management in Patients With Out-of-Hospital Cardiac Arrest: Tracheal Intubation vs. Bag-valve-mask Ventilation - CAAM STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Out-of-hospital Cardiac Arrest
Keywords: Out-of-hospital cardiac arrest
Bag-valve-mask ventilation
Tracheal intubation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 2043
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less.
timeFrame: Day 28
Secondary outcomes:
measure: Survival at hospital admission
timeFrame: Day 0
measure: Survival
timeFrame: Day 28
measure: Survival at hospital discharge
timeFrame: up to Day 28
measure: Neurologic outcomes assessed by modified Rankin scale score
timeFrame: Day 28
measure: Rate of return of spontaneous circulation (ROSC)
timeFrame: Day 0
measure: Intubation difficulty assessed by Intubation difficulty Scale score
timeFrame: Day 0
measure: Complications related to tracheal intubation
timeFrame: Day 0
measure: Complications related to bag-valve-mask ventilation
timeFrame: Day 0
measure: Technique's failure defined as mortality
timeFrame: Day 0, Day 28
measure: Ventilation difficulty with bag-valve-mask measured with a visual-analog-scale (VAS)
timeFrame: Day 0
measure: Han's mask ventilation classification
timeFrame: Day 0
measure: Difficult mask ventilation signs
timeFrame: Day 0
measure: Time to completion of tracheal intubation (TI) procedure
timeFrame: Day 0
measure: Duration of the interruption of chest compression during TI procedure
timeFrame: Day 0
measure: Duration of the interruption of chest compression during advanced CPR (from medical team's arrival to decision to stop CPR)
timeFrame: Day 0
measure: Duration of advanced CPR
timeFrame: Day 0
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Avicenne Hospital - Aphp
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frédéric ADNET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jabre P, Penaloza A, Pinero D, Duchateau FX, Borron SW, Javaudin F, Richard O, de Longueville D, Bouilleau G, Devaud ML, Heidet M, Lejeune C, Fauroux S, Greingor JL, Manara A, Hubert JC, Guihard B, Vermylen O, Lievens P, Auffret Y, Maisondieu C, Huet S, Claessens B, Lapostolle F, Javaud N, Reuter PG, Baker E, Vicaut E, Adnet F. Effect of Bag-Mask Ventilation vs Endotracheal Intubation During Cardiopulmonary Resuscitation on Neurological Outcome After Out-of-Hospital Cardiorespiratory Arrest: A Randomized Clinical Trial. JAMA. 2018 Feb 27;319(8):779-787. doi: 10.1001/jama.2018.0156.