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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04471220
Other study ID # 2019-23
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date September 29, 2022

Study information

Verified date September 2022
Source National Hospital Organization Minami Kyoto Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the exercise capacity (6-min walking distance) under the following 4 conditions using High-flow nasal cannula (HFNC); 1. FIO2 value that the minimum SpO2 value in a 6-minute walking test (6MWT) is 86-88%, and a flow of 10 L/min 2. FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min 3. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min 4. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min


Description:

In the pervious study, the investigators demonstrated that 4 weeks of training using both high FIO2 and high flow through an HFNC significantly improved the 6MWD compared with training using a 6 L/min nasal cannula. However, it was unclear whether the effects of pulmonary rehabilitation under HFNC were due to high FIO2, high flow rate, or a synergistic effect. It is also unknown whether there are differences in the effects of pulmonary rehabilitation under HFNC for each underlying disease.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 29, 2022
Est. primary completion date September 29, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria: - Subjects with a minimum SPO2 of 88% or less during performing 6MWT under HFNC (FIO2 0.21 and a flow rate of 10L/min) - Subjects who have been clinically stable for the last 2 weeks - Subjects with written informed consent to participate in this study Exclusion Criteria: - Subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure - Subjects who needed antimicrobial agent or steroid administration for pneumonia and exacerbation of respiratory disease in the last 2 weeks - Subjects who cannot undergo 6MWT due to severe heart failure, arteriosclerosis obliterans or spinal disease

Study Design


Intervention

Device:
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.

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 Difference in 6MWD between two conditions ("Low FIO2 and high flow rate" and "High FIO2 and high flow rate") through study completion, an average of 2 weeks
Secondary Difference in 6MWD between four conditions through study completion, an average of 2 weeks
Secondary Difference in SpO2 value during 6MWT between four conditions through study completion, an average of 2 weeks
Secondary Difference in Pulse rate value during 6MWT between four conditions through study completion, an average of 2 weeks
Secondary Difference in Dyspnea during 6MWT between four conditions through study completion, an average of 2 weeks
Secondary Difference in lower limb fatigue during 6MWT between four conditions through study completion, an average of 2 weeks
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