High Flow Nasal Cannula on Exercise Endurance in COPD

• ClinicalTrials.gov Identifier: NCT03883256
• Recruitment Status: Completed
• First Posted: March 20, 2019
• Last Update Posted: February 4, 2021
• Sponsor: Chang Gung University
• Information provided by (Responsible Party): Chen Yen-Huey, Chang Gung University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
COPD	Device: high flow nasal cannula; Device: nasal cannula	Not Applicable

Detailed Description:

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effects of High Flow Nasal Cannula on Exercise Endurance in Patients With COPD
• Actual Study Start Date: May 25, 2018
• Actual Primary Completion Date: November 30, 2019
• Actual Study Completion Date: November 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: high flow nasal cannula; Subjects perform a constant-load exercise test with high flow nasal cannula oxygen device.	Device: high flow nasal cannula; 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.
Active Comparator: nasal cannula; Subjects perform a constant-load exercise test with nasal cannula oxygen device.	Device: nasal cannula; Nasal cannula is a device that delivered oxygen to patients. In this study, subjects perform a constant-load exercise test with nasal cannula.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. fever
2. unstable hemodynamics at resting
3. orthopadeic or neurologic problems that limited exercise

Contacts and Locations

Locations

Taiwan

Chang Gung University

TaoYuan City, Taiwan, 333

Sponsors and Collaborators

Chang Gung University

Investigators

• Principal Investigator: Yen-Huey Chen; Chang Gung University

More Information

• Responsible Party: Chen Yen-Huey, assistant professor, Chang Gung University
• ClinicalTrials.gov Identifier: NCT03883256
• Other Study ID Numbers: 201800540A3
• First Posted: March 20, 2019
• Last Update Posted: February 4, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chen Yen-Huey, Chang Gung University:

High flow nasal cannula oxygen; exercise performance; COPD