N/A
N=25
Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients
COPD · Dyspnea
Bottom Line
View on ClinicalTrials.gov: NCT03349437 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Average Distance During Modified 6 Minute Walk Test — 128.0; 129.9; 137.5; 121.3 meters — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitabreath Device (Device); Pursed Lip Breathing (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Philips Respironics
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Distance During Modified 6 Minute Walk Test |
128.0; 129.9; 137.5; 121.3; 265.5; 251.2 | 0.02 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 40
- Ability to provide consent
- COPD diagnosis
- Forced Expiratory Volume in one second (FEV1) 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)
Data sourced from ClinicalTrials.gov (NCT03349437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.