Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients
| Status: | Completed |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 2/24/2019 |
| Start Date: | November 6, 2017 |
| End Date: | February 20, 2018 |
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
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.
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.
Inclusion Criteria:
- Age ≥ 40
- 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.
Exclusion Criteria:
- 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)
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