Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 10
- 主要终点
- Lowest arterial oxygen saturation
研究概览
简要总结
Complications are common during endotracheal intubation of critically ill adults. Manual ventilation between induction and intubation ("bag-valve-mask" ventilation) has been proposed as a means of preventing hypoxemia, the most common complication of intubation outside the operating room. Safety and efficacy data, however, are lacking. PreVent is a randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults. The primary efficacy endpoint will be the lowest arterial oxygen saturation. The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end-expiratory pressure in the 24 hours after the procedure.
详细描述
PreVent is a prospective, parallel-group, pragmatic, randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults. The primary aim of the PreVent trial is to compare the effect of manual ventilation between induction and intubation versus no manual ventilation on the lowest arterial oxygen saturation experienced by critically ill adults undergoing endotracheal intubation. The PreVent trial is anticipated to begin enrollment in January 2017 and will enroll adults undergoing endotracheal intubation with sedation and/or neuromuscular blockade in participating units. Patients will be randomized 1:1 to manual ventilation versus no manual ventilation. In the manual ventilation group, manual ventilation using a bag-valve-mask will be provided from the time of induction until the time of endotracheal intubation, except during laryngoscopy. In the no manual ventilation group, no manual ventilation will be provided between induction and endotracheal intubation, except for the treatment of hypoxemia. The primary efficacy endpoint will be the lowest arterial oxygen saturation during the procedure. The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure in the 24 hours after intubation. Conduct of the trial will be overseen by a Data Safety Monitoring Board. An interim analysis will be performed after the enrollment of 175 patients. The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan made publicly available prior to the conclusion of enrollment. The initial planned enrollment of 350 patients was increased by the Data and Safety Monitoring Board at the interim analysis to a final planned enrollment of 400 patients.
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
- •Patient is located in a participating unit
- •Planned procedure is endotracheal intubation
- •Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
- •Administration of sedation and/or neuromuscular blockade is planned
- •Age ≥ 18 years old
排除标准
- •Urgency of intubation precludes safe performance of study procedures
- •Operator feels a specific approach to ventilation between induction and intubation is required
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Manual Ventilation
Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy. In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
干预措施: Manual Ventilation (Other)
No Manual Ventilation
Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%. For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
干预措施: No Manual Ventilation (Other)
结局指标
主要结局
Lowest arterial oxygen saturation
时间窗: Induction to 2 minutes after completion of the airway management procedure
The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.
次要结局
- Incidence of lowest oxygen saturation less than 90%(Induction to 2 minutes after completion of the airway management procedure)
- Incidence of lowest oxygen saturation less than 80%(Induction to 2 minutes after completion of the airway management procedure)
- Change in saturation from induction to lowest oxygen saturation(Induction to 2 minutes after completion of the airway management procedure)
- Incidence of desaturation(Induction to 2 minutes after completion of the airway management procedure)
- Lowest oxygen saturation in the 24 hours after intubation.(24 hours after intubation)
- Highest fraction of inspired oxygen in the 24 hours after intubation.(24 hours after intubation)
- Highest positive end expiratory pressure in the 24 hours after intubation.(24 hours after intubation)
- Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.(24 hours after intubation)
- Operator-reported pulmonary aspiration(Induction to 2 minutes after completion of the airway management procedure)
- New infiltrate on chest imaging in the 48 hours after intubation(48 hours after intubation)
- Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome)(48 hours after intubation)
- New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation(24 hours after intubation)
- New systolic blood pressure < 65 mmHg or new need for vasopressor(Induction to 2 minutes after completion of the airway management procedure)
- Cardiac arrest within one hour of intubation(One hour after intubation.)
- Death within one hour of intubation(One hour after intubation)
- Cormack-Lehane grade of glottic view(Induction to 2 minutes after completion of the airway management procedure)
- Incidence of esophageal intubation(Induction to 2 minutes after completion of the airway management procedure)
- Lowest systolic blood pressure (peri-procedural)(Induction to 2 minutes after completion of the airway management procedure)
- Operator-assessed difficulty of intubation(Induction to 2 minutes after completion of the airway management procedure)
- Incidence of successful intubation on the first laryngoscopy attempt(Induction to 2 minutes after completion of the airway management procedure)
- Number of laryngoscopy attempts(Induction to 2 minutes after completion of the airway management procedure)
- Need for additional airway equipment or a second operator(Induction to 2 minutes after completion of the airway management procedure)
- In-hospital mortality(28 days)
- Ventilator-free days(28 days)
- Intensive care unit-free days(28 days)
- Time from induction to successful intubation(Induction to 2 minutes after completion of the airway management procedure)
研究者
Matthew Semler
Assistant Professor, Division of Pulmonary and Critical Care Medicine
Vanderbilt University Medical Center