Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation

Chronic Respiratory Failure Clinical Trial

Official title:

Effect of Pulmonary Rehabilitation Under Different Oxygen Concentration Using High-flow Nasal Cannula

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04481295
• Other study ID #: 2019-24
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2020
• Est. completion date: July 2025

Study information

• Verified date: March 2023
• Source: National Hospital Organization Minami Kyoto Hospital
• Contact: Yuichi Chihara
• Phone: 81-774-52-0065
• Email: yc.r03107[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

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, 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.

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Exercise Capacity
• High-flow Nasal Cannula
• Optimal SpO2 Value
• Respiratory Insufficiency

Intervention

Other:
• High-flow nasal cannula
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.
• Low SpO2
Low SpO2

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