Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask
2017年1月15日 更新者：Yandong Jiang、Massachusetts General Hospital
Effect of Continuous Positive Airway Pressure Ventilation Through Nasal Mask on Upper Airway Patency During Induction of Anesthesia
Upper airway obstruction (UAO) is common complication during induction of general anesthesia.
The mechanism of UAO during anesthesia has not been well understood.
Posterior displacement of soft palate are believed to be the primary contributing factors.
The mechanism of UAO during anesthesia share many similarities with obstructive sleep apnea (OSA).
Since nasal continuous positive airway pressure (nCPAP) can maintain the airway patent in patients with OSA, the investigators hypothesize that nCPAP during induction of anesthesia will reduce the incidence and severity of UAO.
研究概览
研究类型
介入性
注册 (实际的)
80
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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Massachusetts
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Boston、Massachusetts、美国、02114
- Anesthesia and Critical Care, Mass General Hospital
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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 至 65年 (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:
Patients,between 18-65 years of age meeting ASA physical status classification I-II requiring general anesthesia for elective surgery who are able to breathe through both their nose and mouth while awake.
Exclusion Criteria:
- Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class III or greater.
- Abnormal vital signs on the day of admission for surgery [heart rate (HR, > 100 bpm or < 40 bpm), blood pressure (BP, > 180/100 mmHg or < 90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) < 96%] that are not correctable with his or her routine medication or commonly used pre-operative medication.
- Unable to open mouth (< 2.5 cm) or unable to breathe through their mouth or nose.
- Subjects with a beard, an abnormal facial structure or other factors precluding obtaining a viable face mask fit without air leak. Also, subjects having claustrophobia that can not tolerate the mask.
- Any person with an anticipated difficult airway. This will include subjects who require or may require either a fiberoptic intubation or intubation while awake and subjects with known OSA or body mass index (BMI) greater than 35 km/m2.
- Gastric-esophageal reflex or a full stomach.
- The subject has remained in bed for more than 24 hours.
- Neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or transient ischemic attack (TIA) within 2 weeks.
- Pregnant women and women less than one month post-partum. Ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. If the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative.
- Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os) guidelines.
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：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 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：Nasal mask with no PEEP
Nasal mask with PEEP 0, then add PEEP 5, and 10
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nasal mask use instead of face mask
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实验性的：Nasal mask with PEEP
Nasal mask with PEEP 5, then add PEEP 10
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nasal mask use instead of face mask
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实验性的：Face mask with no PEEP
Face mask with PEEP 0 then add PEEP 5, 10
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nasal mask use instead of face mask
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实验性的：Face mask with PEEP
Face mask with PEEP 5, then add PEEP 10
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nasal mask use instead of face mask
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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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expired tidal volume
大体时间：Average of one minute after anesthesia induction
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Estimated time from induction of anesthesia (drugs given for anesthesia induction) to apnea is one minute.
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Average of one minute after anesthesia induction
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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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volume of CO2
大体时间：Average of one minute after anesthesia induction
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Estimated time from induction of anesthesia (drugs given for anesthesia induction) to apnea is one minute.
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Average of one minute after anesthesia induction
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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：Yandong Jiang, MD, PhD、Mass. General Hospital
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。
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
2011年10月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2012年5月1日
研究注册日期
首次提交
2012年1月12日
首先提交符合 QC 标准的
2012年1月30日
首次发布 (估计)
2012年2月2日
研究记录更新
最后更新发布 (估计)
2017年1月18日
上次提交的符合 QC 标准的更新
2017年1月15日
最后验证
2017年1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.
nasal mask的临床试验
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Medical University of South Carolina完全的
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Northern Health and Social Care TrustAntrim Area Hospital完全的
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Stephenson Eye Associates招聘中