Initial Airway Management in Patients With Out-of-Hospital Cardiac Arrest: Tracheal Intubation vs. Bag-valve-mask Ventilation - CAAM STUDY
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 2,043
- Locations
- 1
- Primary Endpoint
- Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: bag-valve-mask ventilation (Procedure)
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.
Intervention: tracheal intubation (Procedure)
Outcomes
Primary Outcomes
Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less.
Time Frame: 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
Secondary Outcomes
- Survival at hospital discharge(up to Day 28)
- Neurologic outcomes assessed by modified Rankin scale score(Day 28)
- Ventilation difficulty with bag-valve-mask measured with a visual-analog-scale (VAS)(Day 0)
- Technique's failure defined as mortality(Day 0, Day 28)
- Han's mask ventilation classification(Day 0)
- Rate of return of spontaneous circulation (ROSC)(Day 0)
- Complications related to tracheal intubation(Day 0)
- Survival(Day 28)
- Survival at hospital admission(Day 0)
- Intubation difficulty assessed by Intubation difficulty Scale score(Day 0)
- Complications related to bag-valve-mask ventilation(Day 0)
- Difficult mask ventilation signs(Day 0)
- Duration of the interruption of chest compression during TI procedure(Day 0)
- Time to completion of tracheal intubation (TI) procedure(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(Day 0)