Current State of Endotracheal Intubation Among the Critically Ill and Exploring Risk Factors for Immediate Complications of Endotracheal Intubation: a Prospective, Observational Multi-center Study (HEMAIR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1,288
- 试验地点
- 16
- 主要终点
- Number of participants with Hypoxemia in the 30 minutes following intubation
研究概览
简要总结
In order to examine the current endotracheal intubation practice among critically ill patients, a prospective observational multicenter study of adult critically ill patients was conducted from July 2015 to January 2017 involving 20 ICUs. In this study, the primary aim was to describe, through a prospective observational multicenter study, the current intubation practice of adult critically ill patients undergoing endotracheal intubations with a focus on deriving and validating a prediction model for both immediate airway and hemodynamic complications.
详细描述
Aim 1: To derive and validate a prediction model for difficult airway (three or more attempts at laryngoscopy to place an endotracheal tube and/or the need for another operator among the critically ill) [37].
Aim 2: To derive and validate a prediction model for hemodynamic compromise, i.e., post-intubation hypotension [defined as a decrease at any point in mean arterial pressure less than 65 mmHg; systolic blood pressure less than 80 mm Hg and/or a reduction in systolic blood pressure of 40% from baseline; or the initiation of, or increase in infusion dosage of, any vasopressor medication (bolus or infusion) during the 30 minute period following intubation] [38-39].
Aim3: To derive and validate a predication model for hypoxemia (decrease in pulse oximetry to oxygen saturation less than 88% during the procedure).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 age ≥ 18 years
- •Surgical and medical intensive care unit adult patients
- •Adult patients requiring endotracheal intubation during the time period of study
排除标准
- •Patient age < 18 years
- •Endotracheal intubations performed outside the ICU (in the operating room, in and outside the hospital) are excluded
结局指标
主要结局
Number of participants with Hypoxemia in the 30 minutes following intubation
时间窗: 30 minutes
Number of participants with hypotension in the 30 minutes following intubation
时间窗: 30 minutes
Number of participants with unanticipated difficult airway
时间窗: 10 minutes
defined by 3 or more attempts or two operators
次要结局
- Mechanical ventilation free days in-hospital(28 days or in-hospital)
- Total days of ICU/hospital length of stay(30 days or in-hospital)
- Number of participants with vital status (dead/alive)(30 days or in-hospital)
- Number of participants with disposition to home, nursing home or long term care facility(30 days or in-hospital)