High Flow Nasal Cannula on Exercise Endurance in COPD

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

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: high flow nasal cannula; Device: nasal cannula

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • TaoYuan City, Taiwan, 333
    • Chang Gung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exercise time with high flow nasal cannula	the total duration that subjects performed constant-load exercise test with high flow nasal cannula oxygen device	end of the exercise test in the session of constant-load exercise test with high flow nasal cannula oxygen device
exercise time with nasal cannula	the total duration that subjects performed constant-load exercise test with nasal cannula oxygen device	end of the exercise test in the session of constant-load exercise test with nasal cannula oxygen device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in cardiac output	Difference in end-exercise cardiac output in constant-load exercise test between HFNCO and NC	Baseline and 48 hours after baseline ]
Difference in stroke volume	Difference in end-exercise stroke volume in constant-load exercise test between HFNCO and NC	Baseline and 48 hours after baseline ]
Difference in muscle tissue oxygenation	Difference in end-exercise muscle tissue oxygenation in constant-load exercise test between HFNCO and NC	Baseline and 48 hours after baseline ]
Difference in cerebral tissue oxygenation	Difference in end-exercise cerebral tissue oxygenation in constant-load exercise test between HFNCO and NC	Baseline and 48 hours after baseline ]

Collaborators and Investigators

• Sponsor: Chang Gung University
• Investigators: Principal Investigator: Yen-Huey Chen, Chang Gung University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2018
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: March 10, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (ACTUAL): March 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: COPD; exercise performance; High flow nasal cannula oxygen
• Other Study ID Numbers: 201800540A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No