NCT00972868撤回不适用
Use of a Novel Unidirectional Face Mask During Noninvasive Positive Pressure Ventilation (NPPV) in Chronic Obstructive Pulmonary Disease (COPD) Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Reduction in anatomical dead space and improvement in ventilatory efficiency
研究概览
简要总结
The purpose of this study is to determine the feasibility, safety and efficacy of a unidirectional breathing mask (breathe in through the nose and out through the mouth or breathe in through the mouth and out through the nose) in COPD patients with breathing difficulties requiring noninvasive positive pressure ventilation (NPPV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute hypercapnic respiratory failure as a result of an acute exacerbation of COPD defined as PaCO2 > 50 mmHg, with or without hypoxia, and a respiratory rate of greater than 25/min with the use of accessory muscles of respiration or abdominal paradox;
- •Requiring NPPV as assessed by the managing care team.
排除标准
- •Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;
- •Patients who have claustrophobia and cannot wear the mask;
- •Patients who are hemodynamically unstable;
- •Patients who are disoriented and unable to cooperate with the study procedure;
- •DNI or DNR status or patients in whom intubation is contraindicated;
- •Patients who are currently intubated;
- •Patients who recently (< 6months) had an MI or stroke;
- •Pregnant woman; There will be no exclusion based on gender, race or ethnicity.
研究组 & 干预措施
COPD
Experimental
Thirty adult (> 18 years of age) patients in acute hypercapnic respiratory failure resulting from COPD and requiring Noninvasive Positive Pressure Ventilation (NPPV)
干预措施: A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask) (Device)
结局指标
主要结局
Reduction in anatomical dead space and improvement in ventilatory efficiency
时间窗: 30 minutes
次要结局
- Improvement of ventilation rate, tidal volume, end tidal CO2, arterial pH, PaCO2, and PaO2, SpO2, pulse rate, blood pressure and patient rating of comfort of each ventilatory pattern.(30 minutes)
研究者
Yandong Jiang
Assistant Professor of Anesthesia
Massachusetts General Hospital
研究点 (1)
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