Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial (PreVent)
2018年9月12日 更新者：Matthew Semler、Vanderbilt University Medical Center
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
401
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- The University of Alabama at Birmingham
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Louisiana
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New Orleans、Louisiana、美国、70121
- Ochsner Health System
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New Orleans、Louisiana、美国、70112
- Louisiana State University School of Medicine
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Tennessee
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Nashville、Tennessee、美国、37209
- Vanderbilt University Medical Center
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Washington
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Seattle、Washington、美国、98104
- Harborview Medical Center, University of Washington
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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.
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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.
其他名称：
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有源比较器：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.
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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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Lowest arterial oxygen saturation
大体时间：Induction to 2 minutes after completion of the airway management procedure
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The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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住院死亡率
大体时间：28天
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28天
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Incidence of lowest oxygen saturation less than 90%
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Incidence of lowest oxygen saturation less than 90% in the time from induction to 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Incidence of lowest oxygen saturation less than 80%
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Incidence of lowest oxygen saturation less than 80% in the time from induction to 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Change in saturation from induction to lowest oxygen saturation
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Change in saturation from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Incidence of desaturation
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Incidence of desaturation as defined by a decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Lowest oxygen saturation in the 24 hours after intubation.
大体时间：24 hours after intubation
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24 hours after intubation
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Highest fraction of inspired oxygen in the 24 hours after intubation.
大体时间：24 hours after intubation
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24 hours after intubation
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Highest positive end expiratory pressure in the 24 hours after intubation.
大体时间：24 hours after intubation
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24 hours after intubation
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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.
大体时间：24 hours after intubation
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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.
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24 hours after intubation
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Operator-reported pulmonary aspiration
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Visualization of oropharyngeal or gastric contents in the pharynx, larynx, or trachea between induction and completion of airway management.
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Induction to 2 minutes after completion of the airway management procedure
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New infiltrate on chest imaging in the 48 hours after intubation
大体时间：48 hours after intubation
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Determination of new infiltrate will be made by two blinded experts (pulmonary/critical care attendings or fellows) with adjudication by a third expert in the case of discordant results
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48 hours after intubation
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Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome)
大体时间：48 hours after intubation
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48 hours after intubation
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New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation
大体时间：24 hours after intubation
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24 hours after intubation
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Incidence of esophageal intubation
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Lowest systolic blood pressure (peri-procedural)
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Lowest systolic blood pressure between induction and two minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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New systolic blood pressure < 65 mmHg or new need for vasopressor
大体时间：Induction to 2 minutes after completion of the airway management procedure
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New systolic blood pressure < 65 mmHg or new need for vasopressor between medication administration and 2 minutes following successful placement of an endotracheal tube
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Induction to 2 minutes after completion of the airway management procedure
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Cardiac arrest within one hour of intubation
大体时间：One hour after intubation.
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One hour after intubation.
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Death within one hour of intubation
大体时间：One hour after intubation
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One hour after intubation
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Cormack-Lehane grade of glottic view
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Operator-assessed difficulty of intubation
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Incidence of successful intubation on the first laryngoscopy attempt
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Number of laryngoscopy attempts
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Time from induction to successful intubation
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Need for additional airway equipment or a second operator
大体时间：Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Ventilator-free days
大体时间：28 days
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Ventilator-free days to day 28 will be defined as the number of days alive and with unassisted breathing to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing.
If a patient returns to assisted breathing and subsequently achieves unassisted breathing prior to day 28, VFD will be counted from the end of the last period of assisted breathing to day 28.
If the patient is receiving assisted ventilation at day 28 or dies prior to day 28, VFD will be 0. If a patient is discharged while receiving assisted ventilation, VFD will be 0. All data will be censored at the first of hospital discharge or 28 days.
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28 days
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Intensive care unit-free days
大体时间：28 days
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ICU-free days to 28 days after enrollment will be defined as the number of days alive and not admitted to an intensive care unit service after the patient's final discharge from the intensive care unit in that hospitalization before 28 days.
Patients who are never discharged from the intensive care unit will receive a value of 0. Patients who die before day 28 will receive a value of 0. For patients who return to an ICU and are subsequently discharged prior to day 28, ICU-free days will be counted from the date of final ICU discharge.
All data will be censored at the first of hospital discharge or 28 days.
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28 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Todd W Rice, MD, MSc、Vanderbilt University Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Zouk AN, Gulati S, Heideman BE, Lester MG, Toporek AH, Bentov I, Self WH, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2019 Feb 28;380(9):811-821. doi: 10.1056/NEJMoa1812405. Epub 2019 Feb 18.
- Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Lester MG, Zouk AN, Gulati S, Stigler WS, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial. BMJ Open. 2018 Aug 10;8(8):e022139. doi: 10.1136/bmjopen-2018-022139.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月15日
初级完成 (实际的)
2018年5月6日
研究完成 (实际的)
2018年7月6日
研究注册日期
首次提交
2017年1月16日
首先提交符合 QC 标准的
2017年1月19日
首次发布 (估计)
2017年1月20日
研究记录更新
最后更新发布 (实际的)
2018年9月13日
上次提交的符合 QC 标准的更新
2018年9月12日
最后验证
2018年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.