NCT04947852已完成不适用
Efficacy of NIV Masks in COPD Patients With Chronic Respiratory Failure: A Randomized Controlled Cross Over Pilot
Fisher and Paykel Healthcare2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年7月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Transcutaneous Carbon Dioxide
研究概览
简要总结
A randomized controlled pilot study to compare the efficacy and tolerability of a two different NIV masks on carbon dioxide in participants with stable chronic obstructive pulmonary disease (COPD) with chronic type II respiratory failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •A doctor's diagnosis of COPD
- •PtCO2 ≥45mmHg on transcutaneous monitor at baseline measure
- •Oxygen saturation measured by pulse oximetry (SpO2) ≥85%
- •Fits the study mask
- •Can tolerate the therapy
排除标准
- •FEV1/FVC ≥70%
- •Body mass index >35
- •Hypercapnia considered to be primarily due to Obesity Hypoventilation syndrome and/or Obstructive Sleep Apnea
- •Any condition which makes NIV contra-indicated as per BTS guidelines based on clinical judgement
结局指标
主要结局
Transcutaneous Carbon Dioxide
时间窗: 60 minutes
mmHg
次要结局
- Minute Ventilation(60 minutes)
- Respiratory Rate(60 minutes)
- Oxygen Saturation(60 minutes)
- Heart Rate(60 minutes)
- Borg Dyspnoea Score(60 Minutes)
研究者
研究点 (2)
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