High Flow Nasal Cannula and Exercise Testing in Chronic Obstructive Pulmonary Disease (COPD)

Hospital Italiano de Buenos Aires

Status: Completed

Conditions: COPD

Treatments: Device: High Flow Nasal Cannula Oxygen; Device: Treadmill

Study type: Interventional

Funder types: Other

Identifiers

NCT02860273

2728

Details and patient eligibility

About

In this study the investigators will determine whether the use of High Flow Nasal Cannula Oxygen during test enhances exercise performance in COPD patients on a treadmill.

Full description

Design: interventional, crossover, randomized.

The main goal of this study is to compare the maximum speed reached in an Incremental Load Treadmill Test (ILTT) and max time tolerated in a Constant Treadmill Load Test (CTLT) while using High Flow Nasal Cannula Oxygen (HFNCO).

Patients will be evaluated through two different kinds of tests: Incremental Load Treadmill Test (ILTT) and Constant Treadmill Load Test (CTLT). Each test will be conducted two times, once using High Flow Nasal Cannula Oxygen and the other breathing room air.

In total, each patient will be evaluated four times on four different visits. The testing order will be randomized through STATA.

The following variables will be measured before, during and after each test:

Max speed reached in an Incremental load test: Km/h Max time tolerate in a Constant Load Test: in seconds Oxygen saturation: % Dyspnea: Modified Borg scale (0-10) Cardiac rate: beats per minute Respiratory rate: breaths per minute Blood pressure: mmHg Lower limbs fatigue: modified Borg scale (0-10) Global comfort according to the device used: visual analogue scale (VAS) 0-10

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically stable defined as four weeks without exacerbation.
• Signed Informed consent

Exclusion criteria

• Long term oxygen therapy (LTOT) or oxygen needs during exercise
• Any neuromuscular or cardiovascular condition that limits test performance
• Refusal to participate
• Contraindication for exercise

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

28 participants in 2 patient groups

High Flow Nasal Cannula Oxygen

Experimental group

Description:

1. Incremental Load Treadmill Test (ILTT) using HFNCO at 21% 2. Constant Treadmill Load Test (CTLT) using HFNCO at 21%

Treatment:

Device: High Flow Nasal Cannula Oxygen

Control Group

Other group

Description:

1. Incremental Load Treadmill Test (ILTT) at Room Air 2. Constant Treadmill Load Test (CTLT) at Room Air

Treatment:

Device: Treadmill