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

NCT02858960 | Completed DMC

• 1 other identifier: 2719
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

COPD

Keywords

High Flow Nasal Cannula; COPD; Pulmonary rehabilitation; HFNC; Oxygen

Outcome Measures

Primary Outcomes (2)

• Exercise capacity - Maximum Walking Speed Reached

  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

  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

Study Arms (2)

High Flow Nasal Cannula Oxygen

EXPERIMENTAL

1. Incremental Load Treadmill Test (ILTT) using HFNCO 2. Constant Treadmill Load Test (CTLT) using HFNCO

Device: High Flow Nasal Cannula Oxygen

The Venturi Mask

ACTIVE COMPARATOR

1. Incremental Load Treadmill Test (ILTT) using venturi mask 2. Constant Treadmill Load Test (CTLT) using venturi mask

Device: The Venturi Mask

Interventions

High Flow Nasal Cannula Oxygen DEVICE

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

Also known as: HFNCO

High Flow Nasal Cannula Oxygen

The Venturi Mask DEVICE

Exercise capacity testing according to the oxygen Mask Venturi in COPD patients involved in a Pulmonary Rehabilitation program.

The Venturi Mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Refusal to participate
• Any neuromuscular or cardiovascular or condition that limits test performance.
• Contraindication for exercise

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

Related Publications (22)

• Rabinovich RA, Vilaro J. Structural and functional changes of peripheral muscles in chronic obstructive pulmonary disease patients. Curr Opin Pulm Med. 2010 Mar;16(2):123-33. doi: 10.1097/MCP.0b013e328336438d.

  PMID: 20071991 RESULT

• Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST.

  PMID: 24787074 RESULT

• 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 Molken 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.

  PMID: 24127811 RESULT

• Guell Rous MR, Diaz Lobato S, Rodriguez Trigo G, Morante Velez F, San Miguel M, Cejudo P, Ortega Ruiz F, Munoz A, Galdiz Iturri JB, Garcia A, Servera E; Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR). Pulmonary rehabilitation. Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR). Arch Bronconeumol. 2014 Aug;50(8):332-44. doi: 10.1016/j.arbres.2014.02.014. Epub 2014 May 17. English, Spanish.

  PMID: 24845559 RESULT

• Bolton CE, Blakey JD, Morgan MD; BTS Pulmonary Rehabilitation Guideline Development Group for the Standards of Care Committee for the BTS. The British Thoracic Society guideline on pulmonary rehabilitation in adults: your opinion is noted. Thorax. 2014 Apr;69(4):388-9. doi: 10.1136/thoraxjnl-2013-204754. Epub 2014 Jan 15. No abstract available.

  PMID: 24430178 RESULT

• Sivori M, Almeida M, Benzo R, Boim C, Brassesco M, Callejas O, Capparelli I, Conti E, Diaz M, Draghi J, Franco J, Gando S, Giuliano G, Guida R, Jolly E, Pessolano F, Rabinovich R, Ratto P, Rhodius E, Saadia M, Salvado A, Sobrino E, Victorio C. [New argentine consensus of respiratory rehabilitation 2008]. Medicina (B Aires). 2008;68(4):325-44. Spanish.

  PMID: 18786894 RESULT

• Patessio A, Carone M, Ioli F, Donner CF. Ventilatory and metabolic changes as a result of exercise training in COPD patients. Chest. 1992 May;101(5 Suppl):274S-278S. doi: 10.1378/chest.101.5_supplement.274s.

  PMID: 1576849 RESULT

• O'Donnell DE, D'Arsigny C, Webb KA. Effects of hyperoxia on ventilatory limitation during exercise in advanced chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Mar;163(4):892-8. doi: 10.1164/ajrccm.163.4.2007026.

  PMID: 11282762 RESULT

• Nonoyama ML, Brooks D, Lacasse Y, Guyatt GH, Goldstein RS. Oxygen therapy during exercise training in chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005372. doi: 10.1002/14651858.CD005372.pub2.

  PMID: 17443585 RESULT

• Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

  PMID: 25981908 RESULT

• Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21.

  PMID: 19467849 RESULT

• Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.

  PMID: 25742321 RESULT

• Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.

  PMID: 25866645 RESULT

• Hardinge M, Suntharalingam J, Wilkinson T; British Thoracic Society. Guideline update: The British Thoracic Society Guidelines on home oxygen use in adults. Thorax. 2015 Jun;70(6):589-91. doi: 10.1136/thoraxjnl-2015-206918. Epub 2015 Apr 27.

  PMID: 25918120 RESULT

• Cooper CB, Abrazado M, Legg D, Kesten S. Development and implementation of treadmill exercise testing protocols in COPD. Int J Chron Obstruct Pulmon Dis. 2010 Oct 12;5:375-85. doi: 10.2147/copd.s11153.

  PMID: 21103404 RESULT

• Marrugat J, Vila J, Pavesi M, Sanz F. [Estimation of the sample size in clinical and epidemiological investigations]. Med Clin (Barc). 1998 Sep 12;111(7):267-76. No abstract available. Spanish.

  PMID: 9789243 RESULT

• Laszlo G. Standardisation of lung function testing: helpful guidance from the ATS/ERS Task Force. Thorax. 2006 Sep;61(9):744-6. doi: 10.1136/thx.2006.061648.

  PMID: 16936234 RESULT

• Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.

  PMID: 1759018 RESULT

• Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.

  PMID: 25359355 RESULT

• ERS Task Force; Palange P, Ward SA, Carlsen KH, Casaburi R, Gallagher CG, Gosselink R, O'Donnell DE, Puente-Maestu L, Schols AM, Singh S, Whipp BJ. Recommendations on the use of exercise testing in clinical practice. Eur Respir J. 2007 Jan;29(1):185-209. doi: 10.1183/09031936.00046906.

  PMID: 17197484 RESULT

• Puente-Maestu L, Palange P, Casaburi R, Laveneziana P, Maltais F, Neder JA, O'Donnell DE, Onorati P, Porszasz J, Rabinovich R, Rossiter HB, Singh S, Troosters T, Ward S. Use of exercise testing in the evaluation of interventional efficacy: an official ERS statement. Eur Respir J. 2016 Feb;47(2):429-60. doi: 10.1183/13993003.00745-2015. Epub 2016 Jan 21.

  PMID: 26797036 RESULT

• Casaburi R, Kukafka D, Cooper CB, Witek TJ Jr, Kesten S. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest. 2005 Mar;127(3):809-17. doi: 10.1378/chest.127.3.809.

  PMID: 15764761 RESULT

Related Links

• Global initiative for Chronic Obstructive Lung Disease. Update 2016

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas NR Roux, PT-RT

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: August 8, 2016
• Study Start: April 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: May 9, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

AR (1)