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

Not Applicable

• Conditions: Chronic Obstructive Lung Disease; Interstitial Lung Disease
• Interventions: Device: Tidal Assist Ventilator System; Device: Nasal Cannula Oxygen

• Registration Number: NCT02278107
• Lead Sponsor: New Aera, Inc

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-29
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-26
• Last Update Posted: 2016-02-29
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tidal Assist Ventilator System	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.
Nasal Cannula Oxygen	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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
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