High-flow Nasal Cannula and Exercise Tolerance in COPD

Acute Effects of High-flow Nasal Cannula and Non-invasive Ventilation on Constant-load Exercise Tolerance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Completed
• Conditions: Exercise; Rehabilitation; COPD
• Intervention / Treatment: Other: Control; Other: Non-invasive ventilation; Other: High flow nasal therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • CE
    • Fortaleza, CE, Brazil, 60.430-370
      • Federal University of Ceará

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Previous COPD
• FEV1 ≤ 50%
• Optimized medication

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; The cardiopulmonary exercise test was performed with patient breathing room air.	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.
Active Comparator: NIV; The cardiopulmonary exercise test was performed with non-invasive ventilation during the test.	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.
Active Comparator: HFNT; The cardiopulmonary exercise test was performed with a High flow nasal therapy during the test.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise dinamic hyperinflation	To determine the dinamic hyperinflation during exercise test with 3-different situations , Control, NIV and HFNT. During all testes the dinamic hyperinflation will be measured by inspiratory capacity (at rest and at the end o exercise test) and will be demonstrated as porcentage os maximum.	one week after all tests
Exercise Tolerance	To determine the exercise tolerance with 3-different situations , Control, NIV and HFNT. Time of exercise test will be measured to determine which test could be the best for COPD patients. In additional, the workload will (treadmill inclination and speed) be check to show which intervention has the better response.	one week after all tests

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea	To determine the dyspnea during exercise test with 3-different situations , Control, NIV and HFNT. After all situations, Borg scale will be performed to check the dyspnea score at the end of exercise.	one week after all tests

Collaborators and Investigators

• Sponsor: Marcelo Alcantara Holanda

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: COPD; Non-invasive ventilation; High flow nasal therapy
• Other Study ID Numbers: 3.009.159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is study will be submitted to a medical journal.

Drug and device information, study documents

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