Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC

NCT04471220 | Completed

• 1 other identifier: 2019-23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

High-flow Nasal Cannula; Exercise Capacity; Respiratory Failure

Keywords

HFNC; 6MWD

Outcome Measures

Primary Outcomes (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 Outcomes (5)

• Difference in 6MWD between four conditions

  through study completion, an average of 2 weeks

• Difference in SpO2 value during 6MWT between four conditions

  through study completion, an average of 2 weeks

• Difference in Pulse rate value during 6MWT between four conditions

  through study completion, an average of 2 weeks

• Difference in Dyspnea during 6MWT between four conditions

  through study completion, an average of 2 weeks

• Difference in lower limb fatigue during 6MWT between four conditions

  through study completion, an average of 2 weeks

Study Arms (4)

Low FIO2 and low flow rate under HFNC

ACTIVE COMPARATOR

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

Low FIO2 and high flow rate under HFNC

ACTIVE COMPARATOR

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

High FIO2 and low flow rate under HFNC

ACTIVE COMPARATOR

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

High FIO2 and high flow rate under HFNC

ACTIVE COMPARATOR

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

Interventions

High-flow nasal cannula DEVICE

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.

High FIO2 and high flow rate under HFNC; High FIO2 and low flow rate under HFNC; Low FIO2 and high flow rate under HFNC; Low FIO2 and low flow rate under HFNC

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Hospital Organization Minami Kyoto Hospital: lead

Study Sites (1)

National Hospital Organization Minami Kyoto Hospital

Jōyō, Kyoto, 610-0113, Japan

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 15, 2020
• Study Start: July 1, 2020
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

JP (1)