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Completed

NCT Number: NCT02860273

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

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.

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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 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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

High flow nasal cannula oxygen

Device

Exercise capacity testing according to High Flow Nasal Cannula Oxygen at 21% in COPD patients involved in a Pulmonary Rehabilitation program.

Other names: HFNCO

Treadmill

Device

Exercise capacity testing in COPD patients involved in a Pulmonary Rehabilitation Program.

Primary outcomes

  1. Difference in Exercise capacity - Maximun Walking Time Tolerated

    Time frame: Baseline and 48 hs after baseline

    Difference in Maximun Walking time tolerated in a Constant Treadmill Load Test (CTLT) in seconds between HFNCO and Room air

Secondary outcomes

  1. Difference in Dyspnea

    Time frame: Baseline and 48 hs after baseline

    Difference in dyspnea using Modified Borg Scale (0 - 10 points) between HFNCO and Room air

  2. Difference in Cardiac Rate

    Time frame: Baseline and 48 hs after baseline

    Difference in Cardiac Rate (beats per minute) using a pulse oximetry between HFNCO and Room air

  3. Difference in Oxygen Saturation

    Time frame: Baseline and 48 hs after baseline

    Difference in Oxygen Saturation using a pulse oximetry (SpO2) between HFNCO and Room air

  4. Difference in Global Comfort

    Time frame: Baseline and 48 hs after baseline

    Difference in global comfort according to the device used with visual analogue scale (VAS) 0-10 between HFNCO and Room air

  5. Difference in Lower Limbs Fatigue

    Time frame: Baseline and 48 hs after baseline

    Difference in Lower limbs fatigue using modified Borg scale (0-10) between HFNCO and Room air

  6. Difference in Respiratory Rate

    Time frame: Baseline and 48 hs after baseline

    Difference in Respiratory rate in breaths per minute between HFNCO and Room air

  7. Difference in Blood Pressure

    Time frame: Baseline and 48 hs after baseline

    Difference in of Blood pressure in mmHg between HFNCO and Room air

  8. Difference in Exercise capacity - Maximun Walking Speed Reached

    Time frame: Baseline and 48 hs after baseline

    Difference in Maximun walking speed in km/h reached in an Incremental load treadmill test (ILTT) between HFNCO and Room air

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

Exercise Capacity Testing in COPD Patients With High Flow Nasal Cannula

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2016
Registry last updated
May 22, 2023

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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