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

Primary Purpose

Chronic Respiratory Failure, Nasal High Flow Therapy, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
nasal high flow therapy
Sponsored by
National Hospital Organization Minami Kyoto Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Respiratory Failure focused on measuring nasal high flow therapy, rehabilitation, exercise endurance

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Hospital Organization Minami Kyoto Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

nasal high flow therapy

oxygen therapy

Arm Description

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.

In this group, patients have undergone rehabilitation under the oxygen therapy via a nasal canula (6 L/min) during four weeks.

Outcomes

Primary Outcome Measures

Walk distance (measured by six minutes walking test)

Secondary Outcome Measures

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

Full Information

First Posted
June 13, 2016
Last Updated
May 26, 2018
Sponsor
National Hospital Organization Minami Kyoto Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02804243
Brief Title
The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure
Official Title
The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Hospital Organization Minami Kyoto Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Failure, Nasal High Flow Therapy, Rehabilitation, Exercise Endurance
Keywords
nasal high flow therapy, rehabilitation, exercise endurance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nasal high flow therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
oxygen therapy
Arm Type
No Intervention
Arm Description
In this group, patients have undergone rehabilitation under the oxygen therapy via a nasal canula (6 L/min) during four weeks.
Intervention Type
Device
Intervention Name(s)
nasal high flow therapy
Intervention Description
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 Outcome Measure Information:
Title
Walk distance (measured by six minutes walking test)
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.)
Time Frame
Four weeks
Title
Exercise tolerance test (exercise time et.)
Time Frame
Four weeks
Title
Body composition measured by InBody (muscle mass et.)
Time Frame
Four weeks
Title
Arterial blood gas
Time Frame
Four weeks
Title
Inflammation (CRP et.)
Time Frame
Four weeks
Title
Nutritional status (body mass index(kg/m2) et.)
Time Frame
Four weeks
Title
Sympathetic activity (Catecholamine et.)
Time Frame
Four weeks
Title
Dyspnea (Modified Borg scale)
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Hospital Organization Minami Kyoto Hospital
City
Joyo
State/Province
Kyoto
ZIP/Postal Code
610-0113
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
35644803
Citation
Chihara Y, Tsuboi T, Sumi K, Sato A. Effectiveness of high-flow nasal cannula on pulmonary rehabilitation in subjects with chronic respiratory failure. Respir Investig. 2022 Sep;60(5):658-666. doi: 10.1016/j.resinv.2022.05.002. Epub 2022 May 26.
Results Reference
derived

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

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