High-flow Nasal Cannula and Exercise Tolerance in COPD

NCT ID: NCT04350970

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-12-20

Brief Summary

Patients with COPD are often unable to sustain a sufficient workload during exercise. The use of external strategies to improve exercise tolerance, such as non-invasive ventilation (NIV) and high-flow nasal therapy (HFNT) have been used. The objective was to evaluate and compare the acute effects of HFNT and NIV during exercise on cardiorespiratory parameters, dyspnea, exercise tolerance and comfort in patients with moderate to severe COPD.

Detailed Description

The patients underwent an initial clinical examination, with anthropometric evaluation, blood gas analysis, pulmonary function tests and measurement of maximum respiratory pressures. The exercise protocol started in the sector of Ergometry and Cardiopulmonary Exercise Testing. After completing the maximum incremental cardiopulmonary exercise test, two additional visits were scheduled for the three constant load tests. All patients studied underwent an evaluation of cardiopulmonary exercise testing (CPET). During maximum-incremental CPET, breath by breath: oxygen consumption (V̇O2, mL/min), carbon dioxide production (V̇CO2, mL/min), respiratory exchange rate (RER), minute ventilation VE (L/min), respiratory rate (bpm), equivalent ventilation for O2 and CO2 (V̇E/V̇O2 and V̇E/V̇CO2). In addition, cardiac monitoring was performed by 12-lead electrocardiogram (ECG) throughout the procedure. On the day of the experiment, the patients underwent two cardiopulmonary exercises with constant-load at 90% of the previously determined peak, separated by an interval of at least 1 hour.

The NIV parameters were adjusted for each patient with Trilogy 100 (Philips™). Spontaneous ventilation mode was set before the protocol for all patients, and a previous period of NIV adaptation was performed to titrate the inspiratory and expiratory pressures. The adaptation period started with the minimum Inspiratory Positive Airway Pressure (IPAP) value of 15cmH2O, and, every 2 minutes, increasing the pressure every 2 cmH2O according to the patient's tolerance.16 The Expiratory Positive Airway Pressure (EPAP) was programmed to vary between 4 and 6 cmH2O. Before the start of the examination, an adaptation was performed with the selected mask and initial ventilator settings for 20 min. No additional oxygen was offered.

The high flow system used was Optiflow® (Fisher & Paykel Healthcare, Auckland, New Zealand). Before the test, flow titration was performed for the patient, which started with the administration of a minimum gas flow of 30L/min and, every 2 minutes, the flow was increased by 5L/min according to patient tolerance. The test only started after 20 minutes of adaptation.

Conditions

COPD; Rehabilitation; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control

The cardiopulmonary exercise test was performed with patient breathing room air.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The control test was performed with no additional therapy.

NIV

The cardiopulmonary exercise test was performed with non-invasive ventilation during the test.

Group Type: ACTIVE_COMPARATOR

Non-invasive ventilation

Intervention Type: OTHER

All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The NIV was used during all exercise test.

HFNT

The cardiopulmonary exercise test was performed with a High flow nasal therapy during the test.

Group Type: ACTIVE_COMPARATOR

High flow nasal therapy

Intervention Type: OTHER

All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The high flow nasal therapy was used during all exercise test.

Interventions

High flow nasal therapy

All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The high flow nasal therapy was used during all exercise test.

Intervention Type: OTHER

Non-invasive ventilation

All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The NIV was used during all exercise test.

Intervention Type: OTHER

Control

All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The control test was performed with no additional therapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Previous COPD
• FEV1 ≤ 50%
• Optimized medication

Exclusion Criteria

• COPD Exacerbation
• Cardiac disease
• Previous neurologic disorders
• Unable to complete all protocol

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marcelo Alcantara Holanda

OTHER

Sponsor Role: lead

Responsible Party

Marcelo Alcantara Holanda

Clinical Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Federal University of Ceara

Fortaleza, Ceará, Brazil

Countries

Brazil

Other Identifiers

3.009.159

Identifier Type: -

Identifier Source: org_study_id