Out-of-hospital Cardiac Arrest
Conditions
Keywords
Out-of-hospital cardiac arrest, Bag-valve-mask ventilation, Tracheal intubation
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.
Interventions
PROCEDUREbag-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.
PROCEDUREtracheal 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
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 0 | Complications related to tracheal intubation during advanced Cardiopulmonary Resuscitation (CPR): failure, esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, extubation |
| Complications related to bag-valve-mask ventilation | Day 0 | Complications related to bag-valve-mask ventilation during advanced CPR: regurgitation of gastric content |
| Survival at hospital admission | Day 0 | — |
| 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 | 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 TI procedure | Day 0 | Duration of the interruption of chest compression during TI procedure |
| 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) |
| 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) |
Countries
France
Outcome results
None listed