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

February 26, 2016 updated by: New Aera, Inc

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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:
  • TAV
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:
  • Standard oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Endurance Time to Maximum Tolerance
Time Frame: 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).
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
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Aera, Inc

Investigators

  • Principal Investigator: Richard Kops, MD, John Muir Medical Center, Concord Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 29, 2014

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JM-001-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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