Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC

• Sponsor: National Hospital Organization Minami Kyoto Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04471220
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 29
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
High-flow Nasal Cannula; Exercise Capacity; Respiratory Failure	Device: High-flow nasal cannula	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Examination of Exercise Capacity Under Various Oxygen Concentrations and Oxygen Flow Rates Using High Flow Nasal Cannula
• Actual Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low FIO2 and low flow rate under HFNC 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).	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.
Active Comparator: Low FIO2 and high flow rate under HFNC 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).	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.
Active Comparator: High FIO2 and low flow rate under HFNC 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).	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.
Active Comparator: High FIO2 and high flow rate under HFNC 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).	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Difference in 6MWD between four conditions [through study completion, an average of 2 weeks]

2. Difference in SpO2 value during 6MWT between four conditions [through study completion, an average of 2 weeks]

3. Difference in Pulse rate value during 6MWT between four conditions [through study completion, an average of 2 weeks]

4. Difference in Dyspnea during 6MWT between four conditions [through study completion, an average of 2 weeks]

5. Difference in lower limb fatigue during 6MWT between four conditions [through study completion, an average of 2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Hospital Organization Minami Kyoto Hospital	Joyo	Kyoto	Japan	610-0113

Sponsors and Collaborators

• National Hospital Organization Minami Kyoto Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Hospital Organization Minami Kyoto Hospital
• ClinicalTrials.gov Identifier: NCT04471220
• Other Study ID Numbers: 2019-23
• First Posted: Jul 15, 2020
• Last Update Posted: Sep 5, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Hospital Organization Minami Kyoto Hospital: HFNC; 6MWD
• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

No Results Posted as of Sep 5, 2021