Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC

National Hospital Organization Minami Kyoto Hospital

Status: Completed

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

Treatments: Device: High-flow nasal cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT04471220

2019-23

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

50 participants in 4 patient groups

Low FIO2 and low flow rate under HFNC

Active Comparator group

Description:

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).

Treatment:

Device: High-flow nasal cannula

Low FIO2 and high flow rate under HFNC

Active Comparator group

Description:

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).

Treatment:

Device: High-flow nasal cannula

High FIO2 and low flow rate under HFNC

Active Comparator group

Description:

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).

Treatment:

Device: High-flow nasal cannula

High FIO2 and high flow rate under HFNC

Active Comparator group

Description:

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).

Treatment:

Device: High-flow nasal cannula