Non Invasive Ventilation in Acute Asthma
研究概览
详细说明
In the past, the mainstay of treatment for patients progressing to respiratory failure from acute asthma was intubation and mechanical ventilation. Newer strategies to prevent these intubations to prevent the inherent complications are being explored in form of various pharmacological means like heliox, magnesium sulfate etc. Non pharmacological strategies among which non invasive positive pressure ventilation (NIPPV) is one of the most challenging after showing success in patients with chronic obstructive airway disease (COPD) and cardiogenic pulmonary edema.
Data on efficacy of NIPPV in the management of AA is sparse but has the potential to improve the management of acute severe asthma. Noninvasive ventilation merits further studies in patients with AA, and some consensus panels have suggested that its widespread application in patients with asthma await such trials.The role of NIPPV is not yet clear and needs further studies and keeping this in view we planned this study to study the role of NIPPV in the management of acute asthma.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Chandigarh、印度、160012
- 招聘中
- PGIMER
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接触:
- Digamber Behera, MD
- 电话号码:00911722756822
- 邮箱:dbehera@indiachest.org
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- History of asthma of at least 1 year
- FEV1 < 50% of predicted (by age, height, and gender) or FEV1 < 200 L/minute
- Respiratory rate > 30 breaths/min
- All patients judged by the attending physician as having an acute attack of asthma ( Inability to speak in sentences in one breath, SaO2 < 92% ,pulsus paradoxus > 10 mm of Hg) -
Exclusion Criteria:
- Smoking history of > 10 years
- Chronic obstructive pulmonary disease
- Endotracheal intubation
- Room air saturation < 88 % or arterial PaO2 < 55 mm of Hg
- Hemodynamic instability defined as systolic BP < 90 mm Hg
- Altered state of consciousness
- Congestive heart failure
- Ischemic heart disease
- Upper airway obstruction
- Facial deformity
- Pregnancy
- Pulmonary infiltrates consistent with pulmonary edema or pneumonia
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:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:A
NIPPV
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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 |
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Improvement in lung function defined as an increase of at least 50% in FEV1 as compared to baseline value on admission or an increase in FEV1 to > 60% of predicted value
大体时间:Time to discharge
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Time to discharge
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Intensive care unit length of stay
大体时间:Time to discharge
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Time to discharge
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Hospital length of stay
大体时间:Time to discharge
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Time to discharge
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次要结果测量
结果测量 |
大体时间 |
---|---|
Improvement in the clinical status
大体时间:Time to discharge
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Time to discharge
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Disappearance of pulsus paradoxus
大体时间:Time to discharge
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Time to discharge
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Improvement in arterial blood gases
大体时间:Time to discharge
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Time to discharge
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Improvement in oxygen saturation
大体时间:Time to discharge
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Time to discharge
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Requirements of FiO2 , medications.
大体时间:Time to discharge
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Time to discharge
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Need for mechanical ventilation
大体时间:Time to discharge
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Time to discharge
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合作者和调查者
调查人员
- 首席研究员:Alok Nath, MD、PGIMER, Chandigarh, India
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
研究完成 (预期的)
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
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.
nippv的临床试验
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University Hospital Tuebingen招聘中
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Daping Hospital and the Research Institute of Surgery...Children's Hospital of Fudan University; Chengdu Women's and Children's Central Hospital; Kunming... 和其他合作者未知
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Edward KasaraskisNational Institute of Neurological Disorders and Stroke (NINDS)完全的
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Zekai Tahir Burak Women's Health Research and Education...未知
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University of MichiganNational Institute of Neurological Disorders and Stroke (NINDS)完全的
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Daping Hospital and the Research Institute of Surgery...完全的
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Canadian Neonatal NetworkCanadian Institutes of Health Research (CIHR); MOUNT SINAI HOSPITAL完全的