Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04471220
• Other study ID #: 2019-23
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: September 29, 2022

Study information

• Verified date: September 2022
• Source: National Hospital Organization Minami Kyoto Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 29, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise Capacity
• High-flow Nasal Cannula
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• High-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.

Locations

Country	Name	City	State
Japan	National Hospital Organization Minami Kyoto Hospital	Joyo	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
National Hospital Organization Minami Kyoto Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in 6MWD between four conditions		through study completion, an average of 2 weeks
Secondary	Difference in SpO2 value during 6MWT between four conditions		through study completion, an average of 2 weeks
Secondary	Difference in Pulse rate value during 6MWT between four conditions		through study completion, an average of 2 weeks
Secondary	Difference in Dyspnea during 6MWT between four conditions		through study completion, an average of 2 weeks
Secondary	Difference in lower limb fatigue during 6MWT between four conditions		through study completion, an average of 2 weeks