Pilot Study to Assess the Effect of Providing Intermittent Positive Airway Pressure in COPD Patients in Order to Relieve Their Exertion Related Shortness of Breath
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Average Distance During Modified 6 Minute Walk Test
研究概览
简要总结
Dyspnea is the most common symptom limiting the ability of COPD patients to perform activities of daily living. Although there has been research involving the benefit of providing Non Invasive Ventilation (NIV) during exercise to increase tolerance overall, there is little research specifically looking at shortening dyspnea recovery times associated with exercise. We hypothesize that providing intermittent non-invasive positive pressure therapy (a form of NIV or PAP) with a handheld device to COPD patients immediately after exertion can relieve their dyspnea, and consequently allow them to be more active. In this study, we are comparing the distance walked as measured by a modified 6-Minute Walk Test (6MWT) of 20 COPD patients using VitaBreath (NIV) device versus Pursed Lip Breathing.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide consent
- •COPD diagnosis
- •Forced Expiratory Volume in one second (FEV1) <55 and ≥ 25 percent of predicted value
- •Perceived Shortness of Breath via the Modified Medical Research Counsel Dyspnea questionnaire (rating of 2 or greater) (Appendix B)
- •Able to follow directions
- •Able to tolerate mild physical activity
- •Pursed Lip Breathing as standard of care
- •No evidence of bullous lung disease (with any bullae greater than 3cm in diameter) as confirmed by a CT scan within the past one year.
排除标准
- •Subjects who are acutely ill, medically complicated or who are medically unstable as determined by the investigator.
- •Suffering from COPD exacerbation at time of enrollment or 60 days prior
- •Subjects who are not currently prescribed oxygen and manifest oxygen desaturation below 88% on the screening 6MWT
- •Subjects with heart disease or neuromuscular disease.
- •Subjects who are not prescribed short-acting bronchodilator medication
- •Patients who have experienced recent barotrauma or pneumothorax
- •Unstable angina or Myocardial Infarction during past month
- •Uncontrolled Hypertension (systolic blood pressure of >180mmHg (millimeters of Mercury) and a diastolic >100mmHg)
- •Heart Rate >120 at rest
- •Subjects who have trouble coordinating their breathing with the device during the device training, or cannot tolerate the device mouthpiece resulting in leaks from the nasal cavity
- •Women of child-bearing potential (WOCP) who are pregnant, breast-feeding, or planning pregnancy during the course of the study. (WOCP must have a negative pregnancy test at every visit)
研究组 & 干预措施
Vitabreath Device
The Philips Respironics investigational device VitaBreath is a handheld, battery powered, intermittent positive airway pressure device that is non-invasive, and provides positive airway pressure (PAP) of 18 cm water (H2O) during inspiration and 8 cm H2O on expiration, thus creating 10 cm H2O of pressure support. Pressure support is defined as the difference between inhalation pressure and exhalation pressure. The study device is intended as an adjunct therapy to relieve shortness of breath in COPD patients who experience exertion-related dyspnea to allow them to be more active. The air is delivered to the patient via a mouthpiece on the device.
干预措施: Vitabreath Device (Device)
Pursed Lip Breathing
Pursed lip breathing is a commonly used technique by COPD patients. That involves exhaling through tightly pressed lips and inhaling through the nose with the mouth closed.
干预措施: Pursed Lip Breathing (Other)
结局指标
主要结局
Average Distance During Modified 6 Minute Walk Test
时间窗: 15 minutes
Compare the average distance walked during modified 6 minute walk test (M 6MWT) by COPD participants using Pursed Lip Breathing (PLB) versus an intermittent positive airway pressure handheld device, VitaBreath.
次要结局
未报告次要终点