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

New Aera, Inc

Status: Unknown

Conditions: Chronic Obstructive Lung Disease; Interstitial Lung Disease

Treatments: Device: Tidal Assist Ventilator System; Device: Nasal Cannula Oxygen

Study type: Interventional

Funder types: Industry

Identifiers

NCT02278107

JM-001-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Tidal Assist Ventilator System

Experimental group

Description:

Lightweight, portable, positive pressure ventilator system with proprietary nasal interface. Ventilator is powered by compressed oxygen delivered by cylinder, concentrator, or wall source.

Treatment:

Device: Tidal Assist Ventilator System

Nasal Cannula Oxygen

Active Comparator group

Description:

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.

Treatment:

Device: Nasal Cannula Oxygen