Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC

Not Applicable

Completed

• Conditions: Respiratory Failure; High-flow Nasal Cannula; Exercise Capacity

• Registration Number: NCT04471220
• Lead Sponsor: National Hospital Organization Minami Kyoto Hospital

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-15
• Status Verified: 2022-09
• Primary Completion: 2022-09-29
• Study Completion: 2022-09-29
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Difference in Dyspnea during 6MWT between four conditions	through study completion, an average of 2 weeks
Difference in SpO2 value during 6MWT between four conditions	through study completion, an average of 2 weeks
Difference in Pulse rate value during 6MWT between four conditions	through study completion, an average of 2 weeks
Difference in lower limb fatigue during 6MWT between four conditions	through study completion, an average of 2 weeks
Difference in 6MWD between four conditions	through study completion, an average of 2 weeks

Trial Locations

Locations (1)

National Hospital Organization Minami Kyoto Hospital; 🇯🇵 Joyo, Kyoto, Japan