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The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure

The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02804243
Enrollment
32
Registered
2016-06-17
Start date
2016-06-30
Completion date
2018-05-31
Last updated
2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Respiratory Failure, Exercise Endurance, Nasal High Flow Therapy, Rehabilitation

Keywords

nasal high flow therapy, rehabilitation, exercise endurance

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.

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.

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.

Sponsors

National Hospital Organization Minami Kyoto Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Walk distance (measured by six minutes walking test)Four weeks

Secondary

MeasureTime frame
Exercise tolerance test (exercise time et.)Four weeks
Body composition measured by InBody (muscle mass et.)Four weeks
Arterial blood gasFour weeks
Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.)Four weeks
Nutritional status (body mass index(kg/m2) et.)Four weeks
Sympathetic activity (Catecholamine et.)Four weeks
Dyspnea (Modified Borg scale)Four weeks
Inflammation (CRP et.)Four weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026