Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial (Check-UP)
2016年9月16日 更新者：Todd Rice、Vanderbilt University
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
260
阶段
- 第四阶段
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
- University of Alabama - Birmingham
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Louisiana
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New Orleans、Louisiana、美国、70115
- Ochsner Medical Center
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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、37232
- Vanderbilt University
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Washington
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Seattle、Washington、美国、98104
- 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:
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
Exclusion Criteria:
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
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 |
|---|---|
|
无干预：Sniffing Position, No Checklist
Patient in the sniffing position without the use of a written checklist
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有源比较器：Sniffing Position, Checklist
Patient in the sniffing position with the use of a written checklist
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Use of a written checklist pre and peri-intubation
其他名称：
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有源比较器：Head of Bed Up, No Checklist
Patient with the head of bed up and without the use of a checklist
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Raising the patient's head of bed to 25 degrees
其他名称：
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有源比较器：Head of Bed Up, Checklist
Patient with the head of bed up and with the use of a checklist
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Use of a written checklist pre and peri-intubation
其他名称：
Raising the patient's head of bed to 25 degrees
其他名称：
|
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 |
|---|---|---|
|
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
大体时间：Time of Induction through 2 minutes after successful intubation
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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
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Time of Induction through 2 minutes after successful intubation
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Lowest Systolic Blood Pressure (Checklist intervention only)
大体时间：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)
|
Time of Induction through 2 minutes after successful intubation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Desaturation
大体时间：Time of Induction through 2 minutes after successful intubation
|
Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation
|
Time of Induction through 2 minutes after successful intubation
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|
Incidence of Hypoxemia
大体时间：Time of Induction through 2 minutes after successful intubation
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Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
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Time of Induction through 2 minutes after successful intubation
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Change in Saturation
大体时间：Time of Induction through 2 minutes after successful intubation
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Change in oxygen saturation from baseline to lowest oxygen saturation
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Time of Induction through 2 minutes after successful intubation
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Grade of First Glottic View
大体时间：Time of Induction through 2 minutes after successful intubation
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Cormack-Lehane grade of view on first intubation attempt
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Time of Induction through 2 minutes after successful intubation
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First Pass Success
大体时间：Time of Induction through 2 minutes after successful intubation
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Placement of an endotracheal tube in the trachea after the first insertion of the laryngoscope into the oral cavity without the use of any other devices
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Time of Induction through 2 minutes after successful intubation
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Number of Intubation Attempts
大体时间：Time of Induction through 2 minutes after successful intubation
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Number of attempts required for successful tube placement
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Time of Induction through 2 minutes after successful intubation
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Time to Intubation
大体时间：Time of Induction through 2 minutes after successful intubation
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Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube
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Time of Induction through 2 minutes after successful intubation
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Need for Assistance
大体时间：Time of Induction through 2 minutes after successful intubation
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Incidence of need for additional intubating equipment, second operator
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Time of Induction through 2 minutes after successful intubation
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Non-hypoxic complications
大体时间：Time of Induction through 2 minutes after successful intubation
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Incidence of non-oxygenation complications - composite of all other recorded complications
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Time of Induction through 2 minutes after successful intubation
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Malposition of Endotracheal Tube
大体时间：Time of Induction through 2 minutes after successful intubation
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Incidence of post-intubation tube malposition on Chest X-Ray (CXR)
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Time of Induction through 2 minutes after successful intubation
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Repositioning Patient
大体时间：Time of Induction through 2 minutes after successful intubation
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Incidence of repositioning patient after procedure initiation
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Time of Induction through 2 minutes after successful intubation
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In-Hospital Mortality
大体时间：From enrollment through the earlier of hospital discharge or 365 days
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Death before hospital discharge
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From enrollment through the earlier of hospital discharge or 365 days
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Ventilator-free Days
大体时间：From enrollment through study day 28
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Days alive and free from mechanical ventilation
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From enrollment through study day 28
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ICU-Free Days
大体时间：From enrollment through study day 28
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Days alive and out of the ICU
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From enrollment through study day 28
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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
- 研究主任：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
- Janz DR, Semler MW, Joffe AM, Casey JD, Lentz RJ, deBoisblanc BP, Khan YA, Santanilla JI, Bentov I, Rice TW; Check-UP Investigators*; Pragmatic Critical Care Research Group. A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults. Chest. 2018 Apr;153(4):816-824. doi: 10.1016/j.chest.2017.08.1163. Epub 2017 Sep 14.
- Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6.
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
2015年7月1日
初级完成 (实际的)
2016年9月1日
研究完成 (实际的)
2016年9月1日
研究注册日期
首次提交
2015年7月6日
首先提交符合 QC 标准的
2015年7月10日
首次发布 (估计)
2015年7月14日
研究记录更新
最后更新发布 (估计)
2016年9月19日
上次提交的符合 QC 标准的更新
2016年9月16日
最后验证
2016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.