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

Not Applicable

Completed

• Conditions: Chronic Respiratory Failure; Nasal High Flow Therapy; Rehabilitation; Exercise Endurance
• Interventions: Device: nasal high flow therapy

• Registration Number: NCT02804243
• Lead Sponsor: National Hospital Organization Minami Kyoto Hospital

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Status Verified: 2017-09
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-26
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nasal high flow therapy	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.

Primary Outcome Measures

Name	Time	Method
Walk distance (measured by six minutes walking test)	Four weeks

Secondary Outcome Measures

Name	Time	Method
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
Exercise tolerance test (exercise time et.)	Four weeks
Inflammation (CRP et.)	Four weeks
Sympathetic activity (Catecholamine et.)	Four weeks
Dyspnea (Modified Borg scale)	Four weeks
Body composition measured by InBody (muscle mass et.)	Four weeks
Arterial blood gas	Four weeks

Trial Locations

Locations (1)

National Hospital Organization Minami Kyoto Hospital; 🇯🇵 Joyo, Kyoto, Japan