Respiratory Failure Clinical Trial
Official title:
Examination of Exercise Capacity Under Various Oxygen Concentrations and Oxygen Flow Rates Using High Flow Nasal Cannula
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 |
Verified date | September 2022 |
Source | National Hospital Organization Minami Kyoto Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Japan | National Hospital Organization Minami Kyoto Hospital | Joyo | Kyoto |
Lead Sponsor | Collaborator |
---|---|
National Hospital Organization Minami Kyoto Hospital |
Japan,
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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