High Flow Nasal Cannula on Exercise Endurance in COPD

NCT ID: NCT03883256

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-25
• Study Completion Date: 2019-11-30

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).

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

high flow nasal cannula

Subjects perform a constant-load exercise test with high flow nasal cannula oxygen device.

Group Type: ACTIVE_COMPARATOR

high flow nasal cannula

Intervention Type: 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

Subjects perform a constant-load exercise test with nasal cannula oxygen device.

Group Type: ACTIVE_COMPARATOR

nasal cannula

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung University

OTHER

Sponsor Role: lead

Responsible Party

Chen Yen-Huey

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yen-Huey Chen

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

Chang Gung University

Taoyuan, , Taiwan

Countries

Taiwan

Other Identifiers

201800540A3

Identifier Type: -

Identifier Source: org_study_id