High Flow Nasal Cannula on Exercise Endurance in COPD

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883256
• Other study ID #: 201800540A3
• Status: Completed
• Phase: N/A
• Start date: May 25, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: February 2021
• Source: Chang Gung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung University	TaoYuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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 ]
Secondary	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 ]
Secondary	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 ]
Secondary	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 ]