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

H

Hospital Italiano de Buenos Aires

Status

Completed

Conditions

COPD

Treatments

Device: The Venturi Mask
Device: High Flow Nasal Cannula Oxygen

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

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 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:

  1. Max speed reached in an Incremental load test: Km/h
  2. Max time tolerate in a Constant Load Test: in seconds
  3. Oxygen saturation: %
  4. Dyspnea: Modified Borg scale (0-10)
  5. Cardiac rate: beats per minute
  6. Respiratory rate: breaths per minute
  7. Blood pressure: mmHg
  8. Lower limbs fatigue: modified Borg scale (0-10)
  9. 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

  • 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

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 2. Constant Treadmill Load Test (CTLT) using HFNCO
Treatment:
Device: High Flow Nasal Cannula Oxygen
The Venturi Mask
Active Comparator group
Description:
1. Incremental Load Treadmill Test (ILTT) using venturi mask 2. Constant Treadmill Load Test (CTLT) using venturi mask
Treatment:
Device: The Venturi Mask

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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