A Prospective Trial of Elective Extubation in Brain Injured Patients.
A Prospective Trial of Elective Extubation in Brain Injured Patients Meeting Extubation Criteria for Ventilatory Support.
Identifying the optimal time of extubation in a brain injured population should improve patient outcome. Brain injured patients usually remain intubated due to concerns of airway maintenance. Current practice argues that unconscious patients need to remain intubated to protect their airways. More recent data however suggests that delaying extubation in this population increases pneumonias and worsens patient outcomes.
We designed a safety and feasibility study of randomizing brain injured patients into early or delayed extubation. The purpose was to gain insight into patient safety concerns and to obtain estimates of sample size needed for a larger study.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Resolution or improvement of any pulmonary process requiring mechanical ventilation.
- Adequate gas exchange.
- Adequate ventilation.
- Respiratory rate to tidal volume ratio <105.
- Core body temperature < 38 degrees celsius.
- Hemoglobin > 8 grams per deciliter.
- No sedative medications for 2 hours.
Neurological requirements included:
- GCS ≤ 8.
- Intracranial pressure (ICP) < 15 cm of water and a cerebral perfusion pressure (CPP) > 60 mm Hg for patients with intracranial pressure monitors.
Exclusion Criteria:
- Age < 18 years.
- Lack of informed consent by the patients' surrogate.
- Dependence on mechanical ventilation for at least two weeks prior to enrollment.
- Patients with tracheostomies.
- Intubation instituted for therapeutic hyperventilation.
- Planned surgical or radiological intervention within the next 72 hours.
- Anticipated neurological or medically worsening conditions (i.e develop cerebral edema or vasospasm).
- Patients intubated for airway preservation due to airway edema (cervical neck injuries or surgery) as opposed to airway protection.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:armA I
Patients remain intubated until the patients Glasgow coma score improves to greater than 8.
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patients remain intubated until their Glasgow coma scores improve to greater than 8.
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实验性的:arm 2
Patients that meet standard airway and ventilatory criteria for extubation but have a Glasgow coma score of less than or equal to 8 are immediately extubated.
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Brian injured patients that remained intubation solely because of a depressed level of consciousness were randomized into immediate extubation or delayed extubation until their level of consciousness improved.All patients met standard ventilatory, and airway criteria for extubation.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
改良兰金评分
大体时间:6个月
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6个月
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次要结果测量
结果测量 |
大体时间 |
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nosocomial pneumonias
大体时间:hospital discharge
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hospital discharge
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reintubations
大体时间:hospital discharge
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hospital discharge
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ICU length of stay
大体时间:hospital discharge
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hospital discharge
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hospital length of stay
大体时间:hospital discharge
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hospital discharge
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合作者和调查者
赞助
调查人员
- 研究主任:Edward M. Manno, M.D.、Mayo Clinic
出版物和有用的链接
一般刊物
- Coplin WM, Pierson DJ, Cooley KD, Newell DW, Rubenfeld GD. Implications of extubation delay in brain-injured patients meeting standard weaning criteria. Am J Respir Crit Care Med. 2000 May;161(5):1530-6. doi: 10.1164/ajrccm.161.5.9905102.
- Manno EM, Rabinstein AA, Wijdicks EF, Brown AW, Freeman WD, Lee VH, Weigand SD, Keegan MT, Brown DR, Whalen FX, Roy TK, Hubmayr RD. A prospective trial of elective extubation in brain injured patients meeting extubation criteria for ventilatory support: a feasibility study. Crit Care. 2008;12(6):R138. doi: 10.1186/cc7112. Epub 2008 Nov 10.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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