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

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804243
• Other study ID #: 27-10
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: May 2018

Study information

• Verified date: September 2017
• Source: National Hospital Organization Minami Kyoto Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Exercise Endurance
• Nasal High Flow Therapy
• Rehabilitation
• Respiratory Insufficiency

Intervention

Device:
• nasal high flow therapy
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.

Locations

Country	Name	City	State
Japan	National Hospital Organization Minami Kyoto Hospital	Joyo	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
National Hospital Organization Minami Kyoto Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walk distance (measured by six minutes walking test)		Four weeks
Secondary	Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.)		Four weeks
Secondary	Exercise tolerance test (exercise time et.)		Four weeks
Secondary	Body composition measured by InBody (muscle mass et.)		Four weeks
Secondary	Arterial blood gas		Four weeks
Secondary	Inflammation (CRP et.)		Four weeks
Secondary	Nutritional status (body mass index(kg/m2) et.)		Four weeks
Secondary	Sympathetic activity (Catecholamine et.)		Four weeks
Secondary	Dyspnea (Modified Borg scale)		Four weeks