Evaluation of a Lightweight Nasal Interface and Ventilator in Patients With Respiratory Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tidal Assist Ventilator System Lightweight, portable, positive pressure ventilator system with proprietary nasal interface. Ventilator is powered by compressed oxygen delivered by cylinder, concentrator, or wall source. |
Device: Tidal Assist Ventilator System
Tidal volume augmentation with supplemental oxygen. Source gas options: cylinder, concentrator, wall.
Other Names:
|
| Active Comparator: Nasal Cannula Oxygen Nasal Cannula Oxygen Standard nasal cannula oxygen at 2-5 liters per minute (LPM) based on patient requirement. Oxygen sources includes cylinder, concentrator, or wall source. |
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Exercise Endurance Time to Maximum Tolerance [Maximum exercise endurance in minutes, for both treatment arms. Two 4-hr study visits, 1 week apart. Endurance endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.]
Endurance measured on cycle ergometer at predetermined constant work rate. Subjects will exercise to their limit of tolerability (max effort).
Secondary Outcome Measures
- Borg 10 Dyspnea Score, Subject reported [Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.]
10 point Analog scale
- Arterial Oxygen Saturation via Pulse Oximeter (SpO2) [Recorded 1-2 min before and every 1 minute during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.]
SpO2 measured via forehead and finger pulse oximeters
- Leg Fatigue, Subject Reported [Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.]
10 point Analog scale
- Heart Rate [Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.]
Heart rate recorded by pulse oximeters
- Respiratory Rate [Recorded 1-2 min before and every 1 min during exercise. Evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.]
Respiratory rate recorded by observer
- Adverse Events [Two 4-hr study visits, sheduled 1 week apart. Subjects will be monitored for AEs continuously throughuout the study visit. AEs will be monitored and recored during both study visits.]
Monitoring for observed or reported adverse reactions
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult male or female (> 18 years of age) with a diagnosis of severe-to-very severe chronic lung disease
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Participates in a qualified pulmonary rehabilitation program
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Requires constant flow oxygen of ≥ 2 LPM (liters per minute) during exercise
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Able and willing to sign the informed consent
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Ability to be fitted with the test nasal mask and to use the test ventilator system
Exclusion Criteria:
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Requires > 5LPM of constant flow to maintain SpO2> 90% during exercise
-
Reports having serious epistaxis within the last 14 days prior to enrollment
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Currently enrolled in another clinical study or has participated within 30 days of enrollment
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- New Aera, Inc
Investigators
- Principal Investigator: Richard Kops, MD, John Muir Medical Center, Concord Campus
Study Documents (Full-Text)
None provided.More Information
Publications
- JM-001-2014