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NCT Number: NCT03883256

High Flow Nasal Cannula on Exercise Endurance in COPD

Ventilation limitation has a significant adverse effects on cardiovascular function and cerebral oxygenation during exercise in patients with COPD. High flow nasal cannula (HFNC) has been shown to improve ventilation by washing out the anatomical dead space and permitting a better gas exchanges. Moreover, it is able to ensure the desired inspired oxygen fraction (FiO2) even at high level of patient's minute ventilation by minimizing the room air entrainment. The effects of HFNC on exercise performance in terms of hemodynamic changes and exercise endurance in COPD patients remain unclear. The primary purpose of this study is to examine the effects of HFNC on the exercise endurance in COPD patients. The investigator's secondary purpose is to investigate whether HFNC could improve efficiency of ventilation, leading to an improvement of hemodynamic and cerebral oxygenation response.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung University

Taoyuan City, 333, Taiwan

About this study

This is a randomized crossover study. Patients who have been diagnosed as COPD will be recruited from outpatient department. After signing informed consent form, patients undertake an incremental exercise test and two constant load exercise at the 70% of maximum workload achieved at a previous incremental exercise test on arm ergometer in two separate days. The constant load tests will be performed with HFNC and with nasal cannula at the same inhaled oxygen fraction in random order. The hemodynamics CO, SV, EF of all subjects during exercises will be measured by a bioelectrical impedance device (Physioflow), and cerebral oxygenation status (oxygenated hemoglobin (O2Hb), deoxygenated hemoglobin (HHb), total hemoglobin (tHb) was measured by a near infrared spectrophotometer (NIRS).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • with diagnosis of COPD
  • OPD patients
  • has no AE (within 1 month)
  • not receiving any O2 therapy at home
  • no smoking or quick

Exclusion criteria

  • fever
  • unstable hemodynamics at resting
  • orthopadeic or neurologic problems that limited exercise

Treatment and study plan

High Flow Nasal Cannula

Device

High flow nasal cannula is a device that delivered heated and humidified high flow gases to at or near body temperature to avoid drying and possible injury to the nasal mucosa. In this study, subjects perform a constant-load exercise test with high flow nasal cannula.

Nasal Cannula

Device

Nasal cannula is a device that delivered oxygen to patients. In this study, subjects perform a constant-load exercise test with nasal cannula.

Primary outcomes

  1. exercise time with high flow nasal cannula

    Time frame: end of the exercise test in the session of constant-load exercise test with high flow nasal cannula oxygen device

    the total duration that subjects performed constant-load exercise test with high flow nasal cannula oxygen device

  2. exercise time with nasal cannula

    Time frame: end of the exercise test in the session of constant-load exercise test with nasal cannula oxygen device

    the total duration that subjects performed constant-load exercise test with nasal cannula oxygen device

Secondary outcomes

  1. Difference in cardiac output

    Time frame: Baseline and 48 hours after baseline ]

    Difference in end-exercise cardiac output in constant-load exercise test between HFNCO and NC

  2. Difference in stroke volume

    Time frame: Baseline and 48 hours after baseline ]

    Difference in end-exercise stroke volume in constant-load exercise test between HFNCO and NC

  3. Difference in muscle tissue oxygenation

    Time frame: Baseline and 48 hours after baseline ]

    Difference in end-exercise muscle tissue oxygenation in constant-load exercise test between HFNCO and NC

  4. Difference in cerebral tissue oxygenation

    Time frame: Baseline and 48 hours after baseline ]

    Difference in end-exercise cerebral tissue oxygenation in constant-load exercise test between HFNCO and NC

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Registry information

Official study title

Effects of High Flow Nasal Cannula on Exercise Endurance in Patients With COPD

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2019
Registry last updated
Feb 4, 2021

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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