Initial Airway Management in Patients With Out-of-Hospital Cardiac Arrest: Tracheal Intubation vs. Bag-valve-mask Ventilation - CAAM STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,043
- 试验地点
- 2
- 主要终点
- Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older;
- •Patient with out-of-hospital cardiac arrest on medical team's arrival
- •Resuscitation attempted
- •Medical insurance
排除标准
- •Massive suspected aspiration
- •Presence of do-not-resuscitate order
- •Pregnancy
- •Prisoners
结局指标
主要结局
Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less.
时间窗: 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
次要结局
- 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)