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Completed

NCT Number: NCT04471220

Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC

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

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Key information

Conditions

High-flow Nasal Cannula Exercise Capacity Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital Organization Minami Kyoto Hospital

Jōyō, Kyoto, 610-0113, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: through study completion, an average of 2 weeks

Secondary outcomes

  1. Difference in 6MWD between four conditions

    Time frame: through study completion, an average of 2 weeks

  2. Difference in SpO2 value during 6MWT between four conditions

    Time frame: through study completion, an average of 2 weeks

  3. Difference in Pulse rate value during 6MWT between four conditions

    Time frame: through study completion, an average of 2 weeks

  4. Difference in Dyspnea during 6MWT between four conditions

    Time frame: through study completion, an average of 2 weeks

  5. Difference in lower limb fatigue during 6MWT between four conditions

    Time frame: through study completion, an average of 2 weeks

Sponsors and collaborators

Lead sponsor

National Hospital Organization Minami Kyoto Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2020
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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