Non Invasive Ventilation in Acute Asthma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
The aim of this study is to compare the efficacy of noninvasive positive pressure ventilation versus best medical therapy in patients with acute severe asthma
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) -
排除标准
- •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
- •Pulmonary infiltrates consistent with pulmonary edema or pneumonia
结局指标
主要结局
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
时间窗: Time to discharge
Intensive care unit length of stay
时间窗: Time to discharge
Hospital length of stay
时间窗: Time to discharge
次要结局
- Improvement in the clinical status(Time to discharge)
- Disappearance of pulsus paradoxus(Time to discharge)
- Improvement in arterial blood gases(Time to discharge)
- Improvement in oxygen saturation(Time to discharge)
- Requirements of FiO2 , medications.(Time to discharge)
- Need for mechanical ventilation(Time to discharge)