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
About this trial
This is an interventional supportive care trial for Chronic Obstructive Lung Disease
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
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
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.
Results Reference
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Evaluation of a Lightweight Nasal Interface and Ventilator in Patients With Respiratory Disease
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