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

Primary Purpose

Chronic Obstructive Lung Disease, Interstitial Lung Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tidal Assist Ventilator System
Nasal Cannula Oxygen
Sponsored by
New Aera, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Lung Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tidal Assist Ventilator System

    Nasal Cannula Oxygen

    Arm Description

    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 Standard nasal cannula oxygen at 2-5 liters per minute (LPM) based on patient requirement. Oxygen sources includes cylinder, concentrator, or wall source.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Borg 10 Dyspnea Score, Subject reported
    10 point Analog scale
    Arterial Oxygen Saturation via Pulse Oximeter (SpO2)
    SpO2 measured via forehead and finger pulse oximeters
    Leg Fatigue, Subject Reported
    10 point Analog scale
    Heart Rate
    Heart rate recorded by pulse oximeters
    Respiratory Rate
    Respiratory rate recorded by observer
    Adverse Events
    Monitoring for observed or reported adverse reactions

    Full Information

    First Posted
    October 23, 2014
    Last Updated
    February 26, 2016
    Sponsor
    New Aera, Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02278107
    Brief Title
    Evaluation of a Lightweight Nasal Interface and Ventilator in Patients With Respiratory Disease
    Official Title
    Evaluation of a Lightweight Nasal Interface and Ventilator for Use by Patients With Respiratory Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    New Aera, Inc

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Lung Disease, Interstitial Lung Disease

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tidal Assist Ventilator System
    Arm Type
    Experimental
    Arm Description
    Lightweight, portable, positive pressure ventilator system with proprietary nasal interface. Ventilator is powered by compressed oxygen delivered by cylinder, concentrator, or wall source.
    Arm Title
    Nasal Cannula Oxygen
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    Tidal Assist Ventilator System
    Other Intervention Name(s)
    TAV
    Intervention Description
    Tidal volume augmentation with supplemental oxygen. Source gas options: cylinder, concentrator, wall.
    Intervention Type
    Device
    Intervention Name(s)
    Nasal Cannula Oxygen
    Other Intervention Name(s)
    Standard oxygen therapy
    Intervention Description
    Standard oxygen therapy delivered by nasal cannula at 2-5 lpm based on patient requirements. Source gas options: cylinder, concentrator, wall.
    Primary Outcome Measure Information:
    Title
    Exercise Endurance Time to Maximum Tolerance
    Description
    Endurance measured on cycle ergometer at predetermined constant work rate. Subjects will exercise to their limit of tolerability (max effort).
    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.
    Secondary Outcome Measure Information:
    Title
    Borg 10 Dyspnea Score, Subject reported
    Description
    10 point Analog scale
    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.
    Title
    Arterial Oxygen Saturation via Pulse Oximeter (SpO2)
    Description
    SpO2 measured via forehead and finger pulse oximeters
    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.
    Title
    Leg Fatigue, Subject Reported
    Description
    10 point Analog scale
    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.
    Title
    Heart Rate
    Description
    Heart rate recorded by pulse oximeters
    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.
    Title
    Respiratory Rate
    Description
    Respiratory rate recorded by observer
    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.
    Title
    Adverse Events
    Description
    Monitoring for observed or reported adverse reactions
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Kops, MD
    Organizational Affiliation
    John Muir Medical Center, Concord Campus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23741986
    Citation
    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.
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    Evaluation of a Lightweight Nasal Interface and Ventilator in Patients With Respiratory Disease

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