NCT02627599

A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device

A Study to Evaluate Improvement in the Quality of Life and Health and Economic Outcomes of Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: StratiHealth · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Accepted

Summary

* Evaluate subjects in an prospective observational study * Subjects will be administered scientifically validated questionnaires * Evaluate Quality Improvement and Oxygen Utilization Improvements. 1\. Functional capability, dyspnea, oxygen saturation as primary endpoints 1. Baseline Dyspnea Index (BDI) 2. Transitional Dyspnea Index (TDI) 3. Chronic Respiratory Disease Questionnaire (CRQ) 4. Six minute walk distance (6MWD) 5. Oxygen saturation using pulse oximeter * The secondary endpoints: 1. Portable oxygen source utilization 2. Health care utilization (emergency room encounters, hospital admissions)

Detailed description

Evaluate subjects in an prospective observational study in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine Quality Improvements through using the Breath Responsive Variable Bolus Oxygen Conserving Device with a Portable/Ambulatory Oxygen Source on improvements in functional capability, dyspnea, oxygen saturation, quality of life as primary endpoints, and portable oxygen source utilization, health care utilization as secondary endpoints.

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	Breath Responsive Variable Bolus Oxygen Conserving Device	Mini Electronic Oxygen Conserving Device

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-12-11
• Last updated: 2018-08-15

Locations

3 sites across 1 country: United States