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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Initial Airway Management in Patients With Out-of-Hospital Cardiac Arrest: Tracheal Intubation vs. Bag-valve-mask Ventilation - CAAM STUDY

Conditions
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Out-of-hospital Cardiac Arrest

Intervention / Treatment
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* Procedure: bag-valve-mask ventilation
* Procedure: tracheal intubation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bag-valve-mask ventilation<br>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 | Procedure: bag-valve-mask ventilation<br>* 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.<br>|
| Active Comparator: tracheal intubation<br>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. | Procedure: tracheal intubation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at hospital admission |  | Day 0 | 
| Survival |  | Day 28 | 
| Survival at hospital discharge |  | up to Day 28 | 
| Neurologic outcomes assessed by modified Rankin scale score |  | Day 28 | 
| Rate of return of spontaneous circulation (ROSC) |  | Day 0 | 
| Intubation difficulty assessed by Intubation difficulty Scale score |  | 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 | Day 0 | 
| Complications related to bag-valve-mask ventilation | Complications related to bag-valve-mask ventilation during advanced CPR: regurgitation of gastric content | Day 0 | 
| Technique's failure defined as mortality | 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) |  | Day 0 | 
| Han's mask ventilation classification |  | Day 0 | 
| Difficult mask ventilation signs |  | Day 0 | 
| Time to completion of tracheal intubation (TI) procedure | 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 | 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) | 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 | Duration of advanced CPR (from medical team's arrival to decision to stop CPR) | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Out-of-hospital cardiac arrest, Bag-valve-mask ventilation, Tracheal intubation