Skip to main content
OpenTrials
Completed

NCT Number: NCT02804243

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Respiratory Failure Exercise Endurance Nasal High Flow Therapy Rehabilitation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital Organization Minami Kyoto Hospital

Jōyō, Kyoto, 610-0113, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nasal High Flow Therapy

Device

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.

Primary outcomes

  1. Walk distance (measured by six minutes walking test)

    Time frame: Four weeks

Secondary outcomes

  1. Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.)

    Time frame: Four weeks

  2. Exercise tolerance test (exercise time et.)

    Time frame: Four weeks

  3. Body composition measured by InBody (muscle mass et.)

    Time frame: Four weeks

  4. Arterial blood gas

    Time frame: Four weeks

  5. Inflammation (CRP et.)

    Time frame: Four weeks

  6. Nutritional status (body mass index(kg/m2) et.)

    Time frame: Four weeks

  7. Sympathetic activity (Catecholamine et.)

    Time frame: Four weeks

  8. Dyspnea (Modified Borg scale)

    Time frame: Four weeks

Sponsors and collaborators

Lead sponsor

National Hospital Organization Minami Kyoto Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2016
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.