Clinical trial NCT04471220: Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC
Official title: Examination of Exercise Capacity Under Various Oxygen Concentrations and Oxygen Flow Rates Using High Flow Nasal Cannula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-flow Nasal Cannula
Exercise Capacity
Respiratory Failure
Keywords: HFNC
6MWD
Lead sponsor: National Hospital Organization Minami Kyoto Hospital
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in 6MWD between two conditions ("Low FIO2 and high flow rate" and "High FIO2 and high flow rate")
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: Difference in 6MWD between four conditions
timeFrame: through study completion, an average of 2 weeks
measure: Difference in SpO2 value during 6MWT between four conditions
timeFrame: through study completion, an average of 2 weeks
measure: Difference in Pulse rate value during 6MWT between four conditions
timeFrame: through study completion, an average of 2 weeks
measure: Difference in Dyspnea during 6MWT between four conditions
timeFrame: through study completion, an average of 2 weeks
measure: Difference in lower limb fatigue during 6MWT between four conditions
timeFrame: through study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Joyo
country: Japan
facility: National Hospital Organization Minami Kyoto Hospital
state: Kyoto
Study officials:
References: