Evaluation of a Lightweight Nasal Interface and Ventilator in Patients With Respiratory Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Lightweight Nasal Interface and Ventilator for Use by Patients With Respiratory Disease

Conditions
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Chronic Obstructive Lung Disease, Interstitial Lung Disease

Intervention / Treatment
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* Device: Tidal Assist Ventilator System
* Device: Nasal Cannula Oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tidal Assist Ventilator System<br>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<br>* Tidal volume augmentation with supplemental oxygen. Source gas options: cylinder, concentrator, wall.<br>* Other names: TAV;|
| Active Comparator: Nasal Cannula Oxygen<br>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<br>* Standard oxygen therapy delivered by nasal cannula at 2-5 lpm based on patient requirements. Source gas options: cylinder, concentrator, wall.<br>* Other names: Standard oxygen therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Endurance Time to Maximum Tolerance | Endurance measured on cycle ergometer at predetermined constant work rate. Subjects will exercise to their limit of tolerability (max effort). | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borg 10 Dyspnea Score, Subject reported | 10 point Analog scale | 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. | 
| Arterial Oxygen Saturation via Pulse Oximeter (SpO2) | SpO2 measured via forehead and finger pulse oximeters | 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. | 
| Leg Fatigue, Subject Reported | 10 point Analog scale | 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 | Heart rate recorded by pulse oximeters | 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. | 
| Respiratory Rate | Respiratory rate recorded by observer | 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. | 
| Adverse Events | Monitoring for observed or reported adverse reactions | 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. |