- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02804243
The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure
Study Overview
Status
Intervention / Treatment
Detailed Description
In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. Oxygen supplementation during exercise induced dose-dependent improvement in endurance and symptom perception in chronic obstructive pulmonary disease patients. Recently, nasal high flow therapy which consists of high flow gas with an FiO2 ranging from 0.21 to nearly 1.0 adjusted by an oxygen blender, brought to body temperature, and saturated with water through an in-line humidifier is available.
The present study is randomised to compare the effect of 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Kyoto
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Joyo, Kyoto, Japan, 610-0113
- National Hospital Organization Minami Kyoto Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months.
Exclusion Criteria:
- Subjects with severe cardiovascular disease, diabetes, neurological disease, and renal failure.
- Subject who are unable to undergo rehabilitation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: nasal high flow therapy
In 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.
|
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.
|
No Intervention: oxygen therapy
In this group, patients have undergone rehabilitation under the oxygen therapy via a nasal canula (6 L/min) during four weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Walk distance (measured by six minutes walking test)
Time Frame: Four weeks
|
Four weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.)
Time Frame: Four weeks
|
Four weeks
|
Exercise tolerance test (exercise time et.)
Time Frame: Four weeks
|
Four weeks
|
Body composition measured by InBody (muscle mass et.)
Time Frame: Four weeks
|
Four weeks
|
Arterial blood gas
Time Frame: Four weeks
|
Four weeks
|
Inflammation (CRP et.)
Time Frame: Four weeks
|
Four weeks
|
Nutritional status (body mass index(kg/m2) et.)
Time Frame: Four weeks
|
Four weeks
|
Sympathetic activity (Catecholamine et.)
Time Frame: Four weeks
|
Four weeks
|
Dyspnea (Modified Borg scale)
Time Frame: Four weeks
|
Four weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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