Pragmatic Trial Examining Oxygenation Prior to Intubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,301
- 试验地点
- 32
- 主要终点
- Incidence of Hypoxemia
研究概览
简要总结
Clinicians perform rapid sequence induction, laryngoscopy, and tracheal intubation for more than 5 million critically ill adults as a part of clinical care each year in the United States. One-in-ten emergency tracheal intubations is complicated by life-threatening hypoxemia. Administering supplemental oxygen prior to induction and intubation ("preoxygenation") decreases the risk of life-threatening hypoxemia. In current clinical practice, the most common methods for preoxygenation are non-invasive positive pressure ventilation and facemask oxygen. Prior trials comparing non-invasive positive pressure ventilation and facemask oxygen for preoxygenation have been small and have yielded conflicting results. A better understanding of the comparative effectiveness of these two common, standard-of-care approaches to preoxygenation could improve the care clinicians deliver and patient outcomes.
详细描述
BACKGROUND:
Clinicians frequently perform tracheal intubation of critically ill patients in the emergency department (ED) or intensive care unit (ICU). Complications of intubation, including hypoxemia and cardiovascular instability, occur in nearly half of intubations performed in these settings. Preventing complications during tracheal intubation is a key focus of clinical care and airway management research.
HYPOXEMIA DURING INTUBATION OF CRITICALLY ILL PATIENTS:
Life-threatening hypoxemia occurs in 1-in-10 cases of emergency tracheal intubation. Severe hypoxemia during intubation is associated with increased risk of cardiac arrest and death. Severe hypoxemia may be associated with worse outcomes in survivors. For example, neurologic recovery from traumatic brain injury may be worse after hypoxemia due to secondary ischemic insult.
ROLE OF PREOXYGENATION IN PREVENTING HYPOXEMIA DURING INTUBATION:
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
- •Patient is located in a participating unit
- •Planned procedure is tracheal intubation using a laryngoscope and sedation
- •Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit.
排除标准
- •Patient is receiving positive pressure ventilation by a mechanical ventilator, bag-mask device, or laryngeal mask airway
- •Patient is known to be less than 18 years old
- •Patient is known to be pregnant
- •Patient is known to be a prisoner
- •Immediate need for tracheal intubation precludes safe performance of study procedures
- •Patient is apneic, hypopneic, or has another condition requiring positive pressure ventilation between enrollment and induction
- •Operator has determined that preoxygenation with non-invasive positive pressure ventilation or preoxygenation with a facemask is required or contraindicated for optimal care of the patient
结局指标
主要结局
Incidence of Hypoxemia
时间窗: from induction to 2 minutes following tracheal intubation
A peripheral oxygen saturation \< 85% during the interval between induction and 2 minutes after tracheal intubation
次要结局
- Lowest Oxygen Saturation(from induction to 2 minutes following tracheal intubation)
研究者
Jonathan Casey
Assistant Professor
Vanderbilt University Medical Center