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

NCT ID: NCT02278107

Last Updated: 2016-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-12-31

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.

Conditions

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Chronic Obstructive Lung Disease Interstitial Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tidal Assist Ventilator System

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Nasal Cannula Oxygen

Intervention Type DEVICE

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

Interventions

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Tidal Assist Ventilator System

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

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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TAV Standard oxygen therapy

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Aera, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Kops, MD

Role: PRINCIPAL_INVESTIGATOR

John Muir Medical Center, Concord Campus

References

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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.

Reference Type BACKGROUND
PMID: 23741986 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38199761 (View on PubMed)

Other Identifiers

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JM-001-2014

Identifier Type: -

Identifier Source: org_study_id