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

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ClinicalTrials.gov Identifier: NCT02278107
Recruitment Status : Unknown
Verified February 2016 by New Aera, Inc.
Recruitment status was:  Enrolling by invitation
First Posted : October 29, 2014
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
New Aera, Inc

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Lung Disease Interstitial Lung Disease Device: Tidal Assist Ventilator System Device: Nasal Cannula Oxygen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Lightweight Nasal Interface and Ventilator for Use by Patients With Respiratory Disease
Study Start Date : July 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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 Name: 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 Name: Standard oxygen therapy




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278107


Sponsors and Collaborators
New Aera, Inc
Investigators
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Principal Investigator: Richard Kops, MD John Muir Medical Center, Concord Campus

Publications:
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Responsible Party: New Aera, Inc
ClinicalTrials.gov Identifier: NCT02278107    
Other Study ID Numbers: JM-001-2014
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiration Disorders
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases