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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860273
Recruitment Status : Unknown
Verified February 2018 by Hospital Italiano de Buenos Aires.
Recruitment status was:  Recruiting
First Posted : August 9, 2016
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital Italiano de Buenos Aires

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COPD Device: High Flow Nasal Cannula Oxygen Device: Treadmill Not Applicable

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Capacity Testing in COPD Patients With High Flow Nasal Cannula
Study Start Date : April 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Flow Nasal Cannula Oxygen
  1. Incremental Load Treadmill Test (ILTT) using HFNCO at 21%
  2. Constant Treadmill Load Test (CTLT) using HFNCO at 21%
Device: High Flow Nasal Cannula Oxygen
Exercise capacity testing according to High Flow Nasal Cannula Oxygen at 21% in COPD patients involved in a Pulmonary Rehabilitation program.
Other Name: HFNCO

Control Group
  1. Incremental Load Treadmill Test (ILTT) at Room Air
  2. Constant Treadmill Load Test (CTLT) at Room Air
Device: Treadmill
Exercise capacity testing in COPD patients involved in a Pulmonary Rehabilitation Program.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860273


Contacts
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Contact: Nicolás NR Roux, PT-RT +5411 4959 0200 ext 9814 nicolas.roux@hospitalitaliano.org.ar
Contact: Silvina SD Dell´Era, PT-RT +5411 4959 0200 ext 9814 silvina.dellera@hospitalitaliano.org.ar

Locations
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Argentina
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina, C1181ACH
Contact: HIBA    54-11-49590200 ext 4419      
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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Principal Investigator: Nicolás NR Roux, PT-RT Hospital Italiano de Buenos Aires
Additional Information:
Publications of Results:
Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Mölken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum in: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.

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Responsible Party: Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT02860273    
Other Study ID Numbers: 2728
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Hospital Italiano de Buenos Aires:
Pulmonary Rehabilitation
COPD
High Flow Nasal Cannula
HFNC
Aerobic capacity