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

NCT02278107 | Unknown

• 1 other identifier: JM-001-2014
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Lung Disease; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Tidal Assist Ventilator System

EXPERIMENTAL

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

Nasal Cannula Oxygen

ACTIVE COMPARATOR

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

Interventions

Tidal Assist Ventilator System DEVICE

Tidal volume augmentation with supplemental oxygen. Source gas options: cylinder, concentrator, wall.

Also known as: TAV

Tidal Assist Ventilator System

Nasal Cannula Oxygen DEVICE

Standard oxygen therapy delivered by nasal cannula at 2-5 lpm based on patient requirements. Source gas options: cylinder, concentrator, wall.

Also known as: Standard oxygen therapy

Nasal Cannula Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New Aera, Inc: lead

Related Publications (2)

• Porszasz J, Cao R, Morishige R, van Eykern LA, Stenzler A, Casaburi R. Physiologic effects of an ambulatory ventilation system in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Aug 1;188(3):334-42. doi: 10.1164/rccm.201210-1773OC.

  PMID: 23741986 BACKGROUND

• Hilling L, Cayou C, Kops RS, Ameo RA, Morishige RJ, Glezer S, Hill NS. Effect of a Ventilatory Assist Device in Addition to Supplemental Oxygen on Exercise Endurance in Subjects With COPD. Respir Care. 2024 Apr 22;69(5):527-533. doi: 10.4187/respcare.10875.

  PMID: 38199761 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Kops, MD

  John Muir Medical Center, Concord Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 29, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 29, 2016

Record last verified: 2016-02