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Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC

Examination of Exercise Capacity Under Various Oxygen Concentrations and Oxygen Flow Rates Using High Flow Nasal Cannula

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04471220
Enrollment
50
Registered
2020-07-15
Start date
2020-07-01
Completion date
2022-09-29
Last updated
2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Capacity, High-flow Nasal Cannula, Respiratory Failure

Keywords

HFNC, 6MWD

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.

Interventions

DEVICEHigh-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.

Sponsors

National Hospital Organization Minami Kyoto Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Difference in 6MWD between four conditionsthrough study completion, an average of 2 weeks
Difference in SpO2 value during 6MWT between four conditionsthrough study completion, an average of 2 weeks
Difference in Pulse rate value during 6MWT between four conditionsthrough study completion, an average of 2 weeks
Difference in Dyspnea during 6MWT between four conditionsthrough study completion, an average of 2 weeks
Difference in lower limb fatigue during 6MWT between four conditionsthrough study completion, an average of 2 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026