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Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation

Primary Purpose

High-flow Nasal Cannula, Exercise Capacity, Chronic Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
High-flow nasal cannula
Low SpO2
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 High-flow Nasal Cannula focused on measuring HFNC, 6MWD

Eligibility Criteria

20 Years - 90 Years (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, liver disease, neurological disease, and renal failure.
  • Subjects with a history of hospitalization for pneumonia or exacerbation of respiratory failure within the last month.
  • Subjects with changes in LTOT prescription flow within the last month
  • Subjects who cannot undergo pulmonary rehabilitation due to severe heart failure, arteriosclerosis obliterans or spinal disease.

Sites / Locations

  • National Hospital Organization Minami Kyoto HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High SpO2 group

Low SpO2 group

Arm Description

In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 94-96%, and a flow of 10 L/min).

In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 84-86%, and a flow of 10 L/min).

Outcomes

Primary Outcome Measures

Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation

Secondary Outcome Measures

Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation
Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation
Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitation
Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitation
Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitation
Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitation

Full Information

First Posted
July 19, 2020
Last Updated
March 25, 2023
Sponsor
National Hospital Organization Minami Kyoto Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04481295
Brief Title
Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation
Official Title
Effect of Pulmonary Rehabilitation Under Different Oxygen Concentration Using High-flow Nasal Cannula
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2020 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to compare the exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary 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. However, optimal SpO2 value during pulmonary rehabilitation in patients with chronic respiratory failure receiving long-term oxygen therapy is unclear. The present study is randomized to compare the effect of exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary 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
High-flow Nasal Cannula, Exercise Capacity, Chronic Respiratory Failure, Optimal SpO2 Value
Keywords
HFNC, 6MWD

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High SpO2 group
Arm Type
Active Comparator
Arm Description
In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 94-96%, and a flow of 10 L/min).
Arm Title
Low SpO2 group
Arm Type
Active Comparator
Arm Description
In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 84-86%, and a flow of 10 L/min).
Intervention Type
Other
Intervention Name(s)
High-flow nasal cannula
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.
Intervention Type
Other
Intervention Name(s)
Low SpO2
Intervention Description
Low SpO2
Primary Outcome Measure Information:
Title
Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time Frame
four weeks
Title
Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time Frame
four weeks
Title
Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time Frame
four weeks
Title
Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation
Time Frame
four weeks
Title
Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time Frame
four weeks
Title
Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time Frame
four weeks
Title
Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitation
Time Frame
four weeks
Title
Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitation
Time Frame
four weeks
Title
Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitation
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 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, liver disease, neurological disease, and renal failure. Subjects with a history of hospitalization for pneumonia or exacerbation of respiratory failure within the last month. Subjects with changes in LTOT prescription flow within the last month Subjects who cannot undergo pulmonary rehabilitation due to severe heart failure, arteriosclerosis obliterans or spinal disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuichi Chihara
Phone
81-774-52-0065
Email
yc.r03107@gmail.com
Facility Information:
Facility Name
National Hospital Organization Minami Kyoto Hospital
City
Joyo
State/Province
Kyoto
ZIP/Postal Code
610-0113
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuichi Chihara, MD., PhD.
Phone
81-774-52-0065
Email
yc.r03107@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation

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