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

May 4, 2017 updated by: Hospital Italiano de Buenos Aires

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Flow Nasal Cannula Oxygen
  1. Incremental Load Treadmill Test (ILTT) using HFNCO
  2. Constant Treadmill Load Test (CTLT) using HFNCO
Device: High Flow Nasal Cannula Oxygen
Exercise capacity testing according to High Flow Nasal Cannula Oxygen in COPD patients involved in a Pulmonary Rehabilitation program.
Other Names:
  • HFNCO
Active Comparator: The Venturi Mask
  1. Incremental Load Treadmill Test (ILTT) using venturi mask
  2. Constant Treadmill Load Test (CTLT) using venturi mask
Device: The Venturi Mask
Exercise capacity testing according to the oxygen Mask Venturi in COPD patients involved in a Pulmonary Rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 measurements separated by 48 hs
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.
2 measurements separated by 48 hs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2719

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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