Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease
2016年8月18日 更新者:Breathe Technologies, Inc.
A Pilot Study of the Physiologic Effects of Using the Breathe Technologies Noninvasive Open Ventilation System During Constant Work Rate Exercise in Subjects With Chronic Obstructive Pulmonary Disease
Pilot study in 15 stable male subjects with severe-to-very severe Chronic Obstructive Pulmonary Disease (COPD) to evaluate the effects of short term use of the Breathe Technologies noninvasive open ventilation (NIOV) system on respiratory mechanics during constant work rate exercise in subjects with severe COPD.
研究概览
详细说明
Study was a randomized double-blinded crossover design in which subjects completed a series of exercises at a constant work rate while using 1) Test noninvasive ventilation (NIOV) system powered by compressed air, 2) Test NIOV system powered by 100% oxygen, 3) nasal cannula oxygen, 4) nothing (Control).
Subjects were assessed during constant work rate exercise as reflected by exercise duration, isotime oxygenation (SpO2), and isotime dyspnea score (Borg).
Exercise sessions took place over 4 visits with each visit lasting approximately 5 hours.
研究类型
介入性
注册 (实际的)
15
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
Torrance、California、美国、90502
- Harbor-UCLA Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
- Adult males, ≥ 40 years of age
- Diagnosis of severe COPD (GOLD stage III or IV) defined as having a FEV1 < 50% of predicted and an FEV1/FVC ratio < 70% of predicted
- Ventilatory limitation to exercise, documented by a VE/MVV > 0.85
- SpO2 between 80% and 88% during incremental exercise testing on room air
- Willingness and ability (after training) to exercise on a cycle ergometer
- Willingness and ability to perform all other study related procedures and tasks
- Ability to be properly fitted with the Breathe nasal mask
- Ability to tolerate and be appropriately titrated on the Breathe ventilator (See Appendix E)
- Ability to be properly fitted with an exercise mask
- Fluency in written and spoken English
- Provision of written informed consent
Exclusion Criteria:
- History of acute exacerbation of COPD within 30 days of screening
- History of serious epistaxis within 14 days of screening
- Requirement of > 5 LPM nasal O2 to maintain an SpO2 > 90% while at rest
- History of pneumothorax secondary to lung bullae
- History of intolerance to supplemental oxygen
- Musculoskeletal or other non-pulmonary impairment that limits exercise tolerance
- Inability to achieve an optimal CWR level (4-7 minutes) during Study Visit 1R
- Current participation in another interventional study or participation within 14 days of screening
- Presence of any condition or abnormality that in the opinion of the Principal Investigator may compromise the subject's safety or the quality of the study data
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:NIOV - Room air
Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).
|
Noninvasive ventilation with device powered by compressed room air.
其他名称:
|
实验性的:NIOV - Oxygen
Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).
|
Noninvasive ventilation with device powered by compressed medical (100%) oxygen.
其他名称:
|
有源比较器:Nasal Cannula Oxygen
Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).
|
Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.
其他名称:
|
无干预:No treatment
Control arm.
Subjects exercise without using supplemental oxygen or NIOV.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions
大体时间:Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.
|
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).
|
Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
SpO2 During Constant Workrate Exercise at Isotime
大体时间:Outcome was measured in each of the Study day 1,2, 3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxyg
|
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).
|
Outcome was measured in each of the Study day 1,2, 3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxyg
|
Borg Dyspnea Score During Constant Workrate Exercise at Isotime
大体时间:Outcome was measured in each Study day 1,2,3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and N
|
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control) at isotime. Borg Dyspnea Score ranges in values from 0 to 10. The lower score represent better outcome. 0 = No breathlessness at all, representing better outcome 10 = Maximum breathlessness, representing worse outcome |
Outcome was measured in each Study day 1,2,3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and N
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Richard Casaburi, Ph.D., M.D.、Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年7月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2012年5月1日
研究注册日期
首次提交
2011年6月7日
首先提交符合 QC 标准的
2011年6月10日
首次发布 (估计)
2011年6月14日
研究记录更新
最后更新发布 (估计)
2016年10月12日
上次提交的符合 QC 标准的更新
2016年8月18日
最后验证
2016年8月1日
更多信息
与本研究相关的术语
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.