Clinical trial NCT03883256: High Flow Nasal Cannula on Exercise Endurance in COPD
Official title: Effects of High Flow Nasal Cannula on Exercise Endurance in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: High flow nasal cannula oxygen
exercise performance
COPD
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility 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

Primary outcomes:
measure: exercise time with high flow nasal cannula
timeFrame: end of the exercise test in the session of constant-load exercise test with high flow nasal cannula oxygen device
measure: exercise time with nasal cannula
timeFrame: end of the exercise test in the session of constant-load exercise test with nasal cannula oxygen device
Secondary outcomes:
measure: Difference in cardiac output
timeFrame: Baseline and 48 hours after baseline ]
measure: Difference in stroke volume
timeFrame: Baseline and 48 hours after baseline ]
measure: Difference in muscle tissue oxygenation
timeFrame: Baseline and 48 hours after baseline ]
measure: Difference in cerebral tissue oxygenation
timeFrame: Baseline and 48 hours after baseline ]
Other outcomes:
Locations:
city: TaoYuan City
country: Taiwan
facility: Chang Gung University
Study officials:
affiliation: Chang Gung University
name: Yen-Huey Chen
role: PRINCIPAL_INVESTIGATOR
References: