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Completed

NCT Number: NCT02858960

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

The aim of this study is to compare exercise capacity in COPD patients through two different systems of supplemental oxygen delivery: High Flow Nasal Cannula Oxygen (HFNCO) and The Venturi Mask (VM).

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

About this study

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 two different oxygen delivery devices (High Flow Nasal Cannula Oxygen and The Mask Venturi).

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 HFNCO and the other time with The VM.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Long term oxygen therapy (LTOT) or oxygen needs during exercise.
  • Clinically stable defined as four weeks without exacerbation.

Exclusion criteria

  • Refusal to participate
  • Any neuromuscular or cardiovascular or condition that limits test performance.
  • Contraindication for exercise

Treatment and study plan

High flow nasal cannula oxygen

Device

Exercise capacity testing according to High Flow Nasal Cannula Oxygen in COPD patients involved in a Pulmonary Rehabilitation program.

Other names: HFNCO

The Venturi Mask

Device

Exercise capacity testing according to the oxygen Mask Venturi in COPD patients involved in a Pulmonary Rehabilitation program.

Primary outcomes

  1. Exercise capacity - Maximum Walking Speed Reached

    Time frame: 2 measurements separated by 48 hs

    The exercise capacity test measures the maximum speed (in Km/h) reached during an Incremental Load Treadmill Test (ILTT).

    The test begins at a speed of 3 km/h and each minute after, we will increase the speed by 0.5 km/h.

    The patient will walk until he exhausts his capacity, once reached, the test will finished.

    A second Incremental Load Treadmill Test (ILTT) will be conducted 48 hs afterwards using The Venturi Mask or High Flow Nasal Cannula Oxygen depending on the previous randomization.

  2. Exercise capacity - Maximum Walking Time Reached

    Time frame: 2 measurements separated by 48 hs

    The exercise capacity test measures the maximum time (in minutes) reached during a Constant Load Treadmill Test (CLTT).

    The treadmill speed will be constant and set up at 90% of the maximum speed reached in the previous Incremental Load Treadmill Test (ILTT).

    The patient will walk at the same velocity until he exhausts his capacity thus ending the test.

    A second Constant Load Treadmill Test (CLTT) will be conducted 48 hs following the first Constant Load Treadmill Test (CLTT) using The Venturi Mask or High Flow Nasal Cannula depending on the previous randomization.

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

Comparing Exercise Capacity in Patients With COPD Using High Flow Nasal Cannula Oxygen vs The Venturi Mask

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2016
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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