Status:
UNKNOWN
Evaluation of a Lightweight Nasal Interface and Ventilator in Patients With Respiratory Disease
Lead Sponsor:
New Aera, Inc
Conditions:
Chronic Obstructive Lung Disease
Interstitial Lung Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A preliminary study to evaluate a new nasal interface and portable ventilator system in comparison to standard oxygen therapy in patients with severe chronic lung disease.
Detailed Description
An open-label, randomized, controlled, crossover study in patients with severe chronic lung disease to evaluate exercise tolerance compared to standard nasal cannula oxygen therapy.
Eligibility Criteria
Inclusion
- Adult male or female (\> 18 years of age) with a diagnosis of severe-to-very severe chronic lung disease
- Participates in a qualified pulmonary rehabilitation program
- Requires constant flow oxygen of ≥ 2 LPM (liters per minute) during exercise
- Able and willing to sign the informed consent
- Ability to be fitted with the test nasal mask and to use the test ventilator system
Exclusion
- Requires \> 5LPM of constant flow to maintain SpO2\> 90% during exercise
- Reports having serious epistaxis within the last 14 days prior to enrollment
- Currently enrolled in another clinical study or has participated within 30 days of enrollment
- Has any condition or abnormality that in the opinion of the Investigators may compromise the participant's safety or the quality of the study data
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02278107
Start Date
July 1 2014
End Date
December 1 2016
Last Update
February 29 2016
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.