The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure
1 other identifier
interventional
32
1 country
1
Brief Summary
The purpose of this study is to compare the exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 13, 2016
CompletedFirst Posted
Study publicly available on registry
June 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMay 30, 2018
September 1, 2017
1.9 years
June 13, 2016
May 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Walk distance (measured by six minutes walking test)
Four weeks
Secondary Outcomes (8)
Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.)
Four weeks
Exercise tolerance test (exercise time et.)
Four weeks
Body composition measured by InBody (muscle mass et.)
Four weeks
Arterial blood gas
Four weeks
Inflammation (CRP et.)
Four weeks
- +3 more secondary outcomes
Study Arms (2)
nasal high flow therapy
ACTIVE COMPARATORIn this group, patients have undergone rehabilitation under the nasal high flow therapy (FiO2 100%, oxygen flow from 30 to 60 L/min) during four weeks.
oxygen therapy
NO INTERVENTIONIn this group, patients have undergone rehabilitation under the oxygen therapy via a nasal canula (6 L/min) during four weeks.
Interventions
The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.
Eligibility Criteria
You may qualify if:
- Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months.
You may not qualify if:
- Subjects with severe cardiovascular disease, diabetes, neurological disease, and renal failure.
- Subject who are unable to undergo rehabilitation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Hospital Organization Minami Kyoto Hospital
Jōyō, Kyoto, 610-0113, Japan
Related Publications (1)
Chihara Y, Tsuboi T, Sumi K, Sato A. Effectiveness of high-flow nasal cannula on pulmonary rehabilitation in subjects with chronic respiratory failure. Respir Investig. 2022 Sep;60(5):658-666. doi: 10.1016/j.resinv.2022.05.002. Epub 2022 May 26.
PMID: 35644803DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2016
First Posted
June 17, 2016
Study Start
June 1, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
May 30, 2018
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will share