Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 10
- 主要终点
- Lowest Systolic Blood Pressure (Checklist intervention only)
研究概览
简要总结
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
详细描述
Endotracheal intubation is common in the care of critically ill patients. Procedural complications including hypoxia and hypotension are frequent in urgent and emergent intubation and associated with an increased risk of death. The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial. The investigators propose a randomized trial comparing use of a written checklist versus no written checklist and ramped versus sniffing position for endotracheal intubation of critically ill adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Airway management events will be included in which:
- •Patient is admitted to the Medical Intensive Care Unit (MICU)
- •Planned procedure is endotracheal intubation
- •Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow
- •Administration of sedation and/or neuromuscular blockade is planned
- •Age ≥ 18 years old
排除标准
- •Airway management events will be excluded in which:
- •Operator feels specific patient positioning during intubation is required
- •Urgency of intubation precludes safe performance of study procedures
- •Operator feels an alternative pre-procedure checklist or no checklist is required
结局指标
主要结局
Lowest Systolic Blood Pressure (Checklist intervention only)
时间窗: Time of Induction through 2 minutes after successful intubation
Lowest non-invasively or invasively measured systolic blood pressure between medication administration and 2 minutes following successful placement of an endotracheal tube (in checklist comparison only)
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
时间窗: Time of Induction through 2 minutes after successful intubation
Lowest non-invasively measured arterial oxygen saturation between the time of induction or neuromuscular blockade and two minutes after completion of the airway management procedure
次要结局
- Grade of First Glottic View(Time of Induction through 2 minutes after successful intubation)
- First Pass Success(Time of Induction through 2 minutes after successful intubation)
- Time to Intubation(Time of Induction through 2 minutes after successful intubation)
- Number of Intubation Attempts(Time of Induction through 2 minutes after successful intubation)
- Repositioning Patient(Time of Induction through 2 minutes after successful intubation)
- Incidence of Hypoxemia(Time of Induction through 2 minutes after successful intubation)
- Malposition of Endotracheal Tube(Time of Induction through 2 minutes after successful intubation)
- Change in Saturation(Time of Induction through 2 minutes after successful intubation)
- Non-hypoxic complications(Time of Induction through 2 minutes after successful intubation)
- In-Hospital Mortality(From enrollment through the earlier of hospital discharge or 365 days)
- Incidence of Desaturation(Time of Induction through 2 minutes after successful intubation)
- Need for Assistance(Time of Induction through 2 minutes after successful intubation)
- Ventilator-free Days(From enrollment through study day 28)
- ICU-Free Days(From enrollment through study day 28)
研究者
Todd Rice
Associate Professor of Medicine
Vanderbilt University