High Flow Nasal Cannula and Aerobic Capacity Training

November 16, 2017 updated by: Hospital Italiano de Buenos Aires

High Flow Nasal Cannula Versus The Venturi Mask During Exercise Training in Chronic Obstructive Pulmonary Disease Patients, a Randomized, Simple Blind, Controlled Trial.

The aim of this study is to compare exercise capacity in Chronic Obstructive Pulmonary Disease (COPD) patients before and after an 8 week pulmonary rehabilitation program.

Patients will be randomised in two groups, one arm will received oxygen through High Flow Nasal Cannula (HFNC) and the other group by The Venturi Mask (VM)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Design: randomized, single blind, controlled trial.

The main goal of this study is to compare the exercise tolerance in COPD patients after an 8 week pulmonary rehabilitation program using High Flow Nasal Cannula or The Venturi Mask. The exercise tolerance will be measured in seconds in a Constant Load Treadmill Test (CTLT).

Study Type

Interventional

Enrollment (Anticipated)

60

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
        • Recruiting
        • 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 to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Refusal to participate
  2. Any neuromuscular, cardiovascular or any other condition that limits test performance.
  3. 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: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High Flow Nasal Cannula
During a 8 week Pulmonary Rehabilitation Program patients will receive oxygen through High Flow Nasal Cannula (HFNC) while they are training aerobic capacity on the treadmill.
Device: High Flow Nasal Cannula

During the pulmonary rehabilitation program, patients will train the aerobic capacity on a treadmill. Patients in the intervention arm will receive oxygen trough High Flow Nasal Cannula (HFNC) at 50 lpm and 40% of oxygen.

The aerobic capacity training plan will be conducted three times a week over 24 sessions.

Other Names:
  • HFNC
ACTIVE_COMPARATOR: The Venturi Mask
During a 8 week Pulmonary Rehabilitation Program patients will receive oxygen through The Venturi Mask (VM) while they are training aerobic capacity on the treadmill.
Device: The Venturi Mask

During the pulmonary rehabilitation program, patients will train the aerobic capacity on a treadmill. Patients in the control arm will receive oxygen trough The Venturi Mask (VM) at 40% of oxygen.

The aerobic capacity training plan will be conducted three times a week over 24 sessions.

Other Names:
  • VM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Exercise Capacity - Maximum Walking Time Reached
Time Frame: 8 weeks

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.

This CLTT will be performed three times, always after an Incremental Load Treadmill Test (ILTT)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six Minutes Walking Test
Time Frame: 8 weeks

A Six Minute Walking Test will be conducted according to American Thoracic Society (ATS) guide.

Patients will be asked to walk as much as they can in that period of time. During the test oxygen saturation and cardiac frequency will be recorded.
8 weeks
Exercise capacity - Maximum Walking Speed Reached
Time Frame: 8 weeks

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 3km/h and each minute after will increase by 0.5 km/h.

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

This ILTT will be performed three times, always before the Constant Load Treadmill Test (CLTT)
8 weeks
Quality of Life - The St George's Respiratory Questionnaire
Time Frame: 8 weeks
The St George's Respiratory Questionnaire (SGRQ) is an instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.
8 weeks
Quality of Life -Chronic Obstructive Pulmonary Disease Assessment Test
Time Frame: 8 weeks
The Chronic Obstructive Pulmonary Disease Assessment Test (CAT) is a patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status.
8 weeks
Dyspnea
Time Frame: 8 weeks
The modified Medical research Council Scale (0-4) will be used in order to assess the breathless subjective sensation.
8 weeks
Comfort
Time Frame: 8 weeks
Difference in global comfort according to the device used with visual analogue scale (VAS) 0-10 between High Flow Nasal Cannula and The Venturi Mask
8 weeks

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)

July 1, 2017

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

May 1, 2019

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (ESTIMATE)

November 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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