Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC
- Conditions
- Respiratory FailureHigh-flow Nasal CannulaExercise Capacity
- Interventions
- Device: High-flow nasal cannula
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
- Arm && Interventions
Group Intervention Description Low FIO2 and high flow rate under HFNC High-flow nasal cannula In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min). High FIO2 and low flow rate under HFNC High-flow nasal cannula In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min). High FIO2 and high flow rate under HFNC High-flow nasal cannula In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min). Low FIO2 and low flow rate under HFNC High-flow nasal cannula In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 10 L/min).
- 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