NCT02796599已完成不适用
Impact of Various Interfaces of Non-invasive Ventilation on Performance During Exercise in Patients With Chronic Obstructive Pulmonary Disease
ADIR Association1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Endurance time (Tlim, in second) during Constant Work Load Test (CWLT).
研究概览
简要总结
The purpose of this study is to determine wether the interface (facial or nasal mask) influences performance in patients with chronic obstructive pulmonary disease exercising with non-invasive ventilation.
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
- 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
- •Age > 18 years
- •Chronic obstructive pulmonary disease Gold III-IV
- •Eligible for pulmonary rehabilitation
- •Exercise limitation : at least respiratory limitation (ventilatory reserve ≤ 30%)
- •Non-inclusion Criteria:
- •Pregnant woman or likely to be
- •Familiar with home non-invasive ventilation
- •Patient under guardianship
排除标准
- •Acute exacerbation of chronic obstructive pulmonary disease
研究组 & 干预措施
CWLT with facial mask
Experimental
This study has a cross-over design. Patients will achieve CWLT with non-invasive ventilation using facial or nasal mask in a randomised order.
干预措施: Non invasive ventilation during exercise with facial or nasal mask. (Device)
CWLT with nasal mask
Experimental
This study has a cross-over design. Patients will achieve CWLT with non-invasive ventilation using facial or nasal mask in a randomised order.
干预措施: Non invasive ventilation during exercise with facial or nasal mask. (Device)
结局指标
主要结局
Endurance time (Tlim, in second) during Constant Work Load Test (CWLT).
时间窗: The outcome will be measure after every CWLT. The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
Patients will achieve 3 Constant Work Load Test Under different conditions (1 without noninvasive ventilation and 2 with noninvasive ventilation using in a randomised order facial or nasal mask). Endurance time (sec) will be recorded at the end of every test.
次要结局
- Blood pressure (mmHg) before and after every CWLT using electrical blood pressure device.(The outcome will be assessed before and after every CWLT. The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.)
- Oxygen saturation (SpO2, %) during CWLT using capnograph.(The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.)
- Respiratory rate (rpm) during CWLT with noninvasive ventilation using ventilator monitoring.(The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.)
- Leak (liter per minute) during CWLT with noninvasive ventilation using ventilator monitoring.(The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.)
- Dyspnea during CWLT using modified Borg Scale (0-10).(The outcome will be measure during every CWLT.The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.)
- Comfort of different masks using numerical scale (0-10) after exercising with noninvasive ventilation.(The outcome will be measure after every CWLT achieved with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.)
- Exhaustion during CWLT using modified Borg Scale (0-10).(The outcome will be measure during every CWLT.The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.)
- Heart rate (rpm) during CWLT using capnograph.(The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.)
- Transcutaneous carbon dioxide pressure (PtcCO2, mmHg) during CWLT using capnograph.(The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected.)
- Inspiratory tidal volume (Vti, in liter) during CWLT with noninvasive ventilation using ventilator monitoring.(The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.)
研究者
研究点 (1)
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