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Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC

Primary Purpose

High-flow Nasal Cannula, Exercise Capacity, Respiratory Failure

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

High-flow nasal cannula

About this trial

This is an interventional other trial for High-flow Nasal Cannula focused on measuring HFNC, 6MWD

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

National Hospital Organization Minami Kyoto Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Low FIO2 and low flow rate under HFNC

Low FIO2 and high flow rate under HFNC

High FIO2 and low flow rate under HFNC

High FIO2 and high flow rate under HFNC

Arm 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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Difference in 6MWD between two conditions ("Low FIO2 and high flow rate" and "High FIO2 and high flow rate")

Secondary Outcome Measures

Difference in 6MWD between four conditions

Difference in SpO2 value during 6MWT between four conditions

Difference in Pulse rate value during 6MWT between four conditions

Difference in Dyspnea during 6MWT between four conditions

Difference in lower limb fatigue during 6MWT between four conditions

Full Information

NCT ID

NCT04471220

First Posted

July 7, 2020

Last Updated

September 29, 2022

Sponsor

National Hospital Organization Minami Kyoto Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04471220

Brief Title

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

September 29, 2022 (Actual)

Study Completion Date

September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Hospital Organization Minami Kyoto Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High-flow Nasal Cannula, Exercise Capacity, Respiratory Failure

Keywords

HFNC, 6MWD

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low FIO2 and low flow rate under HFNC

Arm Type

Active Comparator

Arm 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).

Arm Title

Low FIO2 and high flow rate under HFNC

Arm Type

Active Comparator

Arm 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).

Arm Title

High FIO2 and low flow rate under HFNC

Arm Type

Active Comparator

Arm 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).

Arm Title

High FIO2 and high flow rate under HFNC

Arm Type

Active Comparator

Arm 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).

Intervention Type

Device

Intervention Name(s)

High-flow nasal cannula

Intervention Description

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.

Primary Outcome Measure Information:

Title

Difference in 6MWD between two conditions ("Low FIO2 and high flow rate" and "High FIO2 and high flow rate")

Time Frame