Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,004
- 试验地点
- 12
- 主要终点
- Number of Patients Alive at 72 Hours After Episode.
研究概览
简要总结
The primary objective of the trial is to determine if 72-hour survival after out-of-hospital cardiac arrest (OHCA) is improved with initial endotracheal intubation (ETI) over initial laryngeal tube (LT) airway management strategies.
详细描述
The primary objective of the trial is to determine if 72-hour survival after out-of-hospital cardiac arrest (OHCA) is improved with initial endotracheal intubation (ETI) over initial laryngeal tube (LT) airway management strategies.
The null hypothesis is that 72-hour survival is similar between primary Laryngeal Tube (LT) SGA and primary ETI airway management strategies.
Evaluated secondary outcomes will include return of spontaneous circulation, survival to hospital discharge, neurologically intact survival at hospital discharge, airway management performance, and clinical adverse events.
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
- •Out-of-hospital cardiac arrest (OHCA)
- •Adult (age ≥18 years or per local interpretation)
- •Non-traumatic etiology
- •Initiation of ventilatory support (e.g., bag-valve-mask device, non-rebreather mas, etc.)
排除标准
- •Known pregnant women
- •Known prisoners
- •Major facial trauma (visible major deformity, copious oral bleeding, etc)
- •Major bleeding or exsanguination (e.g., major upper or lower GI bleed, visceral perforation, major uncontrolled bleeding from laceration or injury)
- •Patient receiving initial care by a non-PART participating EMS agency capable of performing ETI, LT, or other advanced airway management
- •Patients with ET tube, LT or other advanced airway device inserted prior to participating EMS agency arrival (e.g., inserted by healthcare facility personnel)
- •Patients with a pre-existing tracheostomy
- •Obvious asphyxial cardiac arrest (e.g., choking, foreign body aspiration, angioedema, epiglottitis, trauma to mouth and face, etc.)
- •Patients with a left ventricular assist device (LVAD) or total artificial heart (TAH)
- •Patients with pre-existing written "do-not-attempt-resuscitation" (DNAR) orders
- •Inter-facility transports
- •Patients with a "do not enroll" bracelet
研究组 & 干预措施
Endotracheal Intubation
The insertion of a plastic breathing tube through the mouth and into the trachea.
干预措施: Endotracheal Intubation (Device)
Laryngeal Tube (King)
Insertion of a supraglottic airway (SGA)
干预措施: Laryngeal Tube (King) (Device)
结局指标
主要结局
Number of Patients Alive at 72 Hours After Episode.
时间窗: 72 hours
Number of patient alive at 72 hours after episode.
次要结局
- Return of Spontaneous Circulation (ROSC)(Patients will be followed from the time of the CA until death or ROSC whichever occurs first. The time frame for this secondary outcome may vary from minutes to hours, but is not expected to last longer than 12 hours.)
- Number of Patients Alive at Hospital Discharge(From enrollment through end of hospital course. Maximum time interval not specified. Maximum time interval observed in study was 138 days.)
- Number of Patients With Favorable Neurologic Status on Hospital Discharge(From enrollment through end of hospital course.)
研究者
Henry E. Wang, MD, MS
Principal Investigator
University of Alabama at Birmingham