In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency - Full Text View

Purpose

The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system will accomplish this by providing oxygen under pressure and augmenting the subject's spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted ventilation, and a comfortable low-profile device, will result in a mean improvement in perceived well-being and ability to perform ADLs, as measured by patient-reported outcome (PRO) instruments.

Condition	Intervention
Pulmonary Disease, Chronic Obstructive Airflow Obstruction, Chronic Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease	Device: Breathe NIOV System

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	In-home Evaluation of the Breathe Technologies Noninvasive Open Ventilation (NIOV™) System in Patients With Severe Respiratory Insufficiency

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Oxygen Therapy Respiratory Failure

U.S. FDA Resources

Further study details as provided by Breathe Technologies, Inc.:

Primary Outcome Measures:

Dyspnea Score [ Time Frame: Periodically over four hours ] [ Designated as safety issue: No ]
Borg Dyspnea Score (BDS)
Fatigue Score [ Time Frame: Periodically over four hours ] [ Designated as safety issue: No ]
Fatigue Visual Analogue Scale (VAS)
Comfort Score [ Time Frame: Periodically over four hours ] [ Designated as safety issue: No ]
Comfort Visual Analog Scale (VAS)

Secondary Outcome Measures:

Heart rate [ Time Frame: Up to four hours each study visit ] [ Designated as safety issue: No ]
Respiratory rate [ Time Frame: Up to four hours each study visit ] [ Designated as safety issue: No ]
Oxygen saturation [ Time Frame: Up to four hours each study visit ] [ Designated as safety issue: No ]
Pulse oximetry
Partial pressure of carbon dioxide measured transcutaneously (TcPCO2) [ Time Frame: Periodically over four hours ] [ Designated as safety issue: No ]
Actigraphy [ Time Frame: Up to four hours each study visit ] [ Designated as safety issue: No ]
Actigraphy monitor
Quality of Life (QOL) [ Time Frame: Before intervention begins on the first study day (baseline); at the completion of the first study day; at the completion of study days 2-9. ] [ Designated as safety issue: No ]
Chronic Respiratory Questionnaire

Enrollment:	30
Study Start Date:	May 2011
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Standard Oxygen Therapy	Device: Breathe NIOV System Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator system during selected activities of daily living. Other Names: NIOV Oxygen O2
Experimental: Breathe NIOV System	Device: Breathe NIOV System Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator system during selected activities of daily living. Other Names: NIOV Oxygen O2

Detailed Description:

This will be a prospective, open-label, crossover study in up to 12 stable subjects with chronic respiratory insufficiency who require LTOT. Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator system during selected activities of daily living. Subjects will participate in the study for up to 9 home visits, with Visits 1 and 2 each lasting for approximately 4 hours, and Visits 3-9 lasting approximately 1-2 hours each. Subjects may discontinue study participation at any time.

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult male and female subjects, 21-80 years of age
Diagnosis of chronic respiratory insufficiency including COPD and interstitial lung disease
Requires use of continuous nasal oxygen of at least 2 lpm
Reports limitation of activity due to fatigue or breathlessness
Fluent in written and spoken English language
Ability to be properly fitted with the Breathe nasal mask
Ability to tolerate and be appropriately titrated on the Breathe ventilator
Ability to communicate self-assessment of dyspnea, comfort, and fatigue
Ability and willingness to participate in the study including walking and other activities of daily living
Ability to provide written informed consent

Exclusion Criteria:

Recent history of frequent or severe epistaxis
Symptoms of acute respiratory exacerbation within 48 hours of Study Day 1
Discharge from the hospital within 30 days of study enrollment
Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment or who are unlikely to be able to comply with trial requirements
Subjects with conditions that, in the Investigator's opinion, contraindicates study participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347931

Locations

United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212

Sponsors and Collaborators

Breathe Technologies, Inc.

More Information

No publications provided

Responsible Party:	Breathe Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT01347931 History of Changes
Other Study ID Numbers:	CP-00-0034
Study First Received:	May 3, 2011
Last Updated:	April 20, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency

Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013