Trials / Unknown
UnknownNCT02278107
Evaluation of a Lightweight Nasal Interface and Ventilator in Patients With Respiratory Disease
Evaluation of a Lightweight Nasal Interface and Ventilator for Use by Patients With Respiratory Disease
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- New Aera, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tidal Assist Ventilator System | Tidal volume augmentation with supplemental oxygen. Source gas options: cylinder, concentrator, wall. |
| DEVICE | Nasal Cannula Oxygen | Standard oxygen therapy delivered by nasal cannula at 2-5 lpm based on patient requirements. Source gas options: cylinder, concentrator, wall. |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2014-10-29
- Last updated
- 2016-02-29
Source: ClinicalTrials.gov record NCT02278107. Inclusion in this directory is not an endorsement.