Tracheal Intubation vs. Bag-valve-mask Ventilation in Patients With Out-of-Hospital Cardiac Arrest _ CAAM STUDY
- Conditions
- Out-of-hospital Cardiac Arrest
- Interventions
- Procedure: bag-valve-mask ventilationProcedure: tracheal intubation
- Registration Number
- NCT02327026
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2043
- Age 18 years or older;
- Patient with out-of-hospital cardiac arrest on medical team's arrival
- Resuscitation attempted
- Medical insurance
- Massive suspected aspiration
- Presence of do-not-resuscitate order
- Pregnancy
- Prisoners
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description bag-valve-mask ventilation 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 tracheal intubation 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.
- Primary Outcome Measures
Name Time Method Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less. 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 Outcome Measures
Name Time Method 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 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)
Han's mask ventilation classification Day 0 Rate of return of spontaneous circulation (ROSC) Day 0 Complications related to tracheal intubation Day 0 Complications related to tracheal intubation during advanced Cardiopulmonary Resuscitation (CPR): failure, esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, extubation
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 Complications related to bag-valve-mask ventilation during advanced CPR: regurgitation of gastric content
Difficult mask ventilation signs Day 0 Duration of the interruption of chest compression during TI procedure Day 0 Duration of the interruption of chest compression during TI procedure
Time to completion of tracheal intubation (TI) procedure Day 0 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
Duration of the interruption of chest compression during advanced CPR (from medical team's arrival to decision to stop CPR) Day 0 Duration of the interruption of chest compression during advanced CPR (from medical team's arrival to decision to stop CPR)
Duration of advanced CPR Day 0 Duration of advanced CPR (from medical team's arrival to decision to stop CPR)
Trial Locations
- Locations (1)
Avicenne Hospital - Aphp
🇫🇷Bobigny, Ile de France, France