Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-04-17 @ 11:04 PM
Study NCT ID:
NCT02858960
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2016-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula and Exercise in Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-10-01', 'releaseDate': '2018-02-06'}], 'estimatedResultsFirstSubmitDate': '2018-02-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2016-03-29', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise capacity - Maximum Walking Speed Reached', 'timeFrame': '2 measurements separated by 48 hs', 'description': 'The exercise capacity test measures the maximum speed (in Km/h) reached during an Incremental Load Treadmill Test (ILTT).\n\nThe test begins at a speed of 3 km/h and each minute after, we will increase the speed by 0.5 km/h.\n\nThe patient will walk until he exhausts his capacity, once reached, the test will finished.\n\nA 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.'}, {'measure': 'Exercise capacity - Maximum Walking Time Reached', 'timeFrame': '2 measurements separated by 48 hs', 'description': 'The exercise capacity test measures the maximum time (in minutes) reached during a Constant Load Treadmill Test (CLTT).\n\nThe treadmill speed will be constant and set up at 90% of the maximum speed reached in the previous Incremental Load Treadmill Test (ILTT).\n\nThe patient will walk at the same velocity until he exhausts his capacity thus ending the test.\n\nA 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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['High Flow Nasal Cannula', 'COPD', 'Pulmonary rehabilitation', 'HFNC', 'Oxygen'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '20071991', 'type': 'RESULT', 'citation': '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': '24787074', 'type': 'RESULT', 'citation': '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': '24127811', 'type': 'RESULT', 'citation': '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': '24845559', 'type': 'RESULT', 'citation': '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': '24430178', 'type': 'RESULT', 'citation': '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': '18786894', 'type': 'RESULT', 'citation': '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': '1576849', 'type': 'RESULT', 'citation': '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': '11282762', 'type': 'RESULT', 'citation': "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': '17443585', 'type': 'RESULT', 'citation': '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': '25981908', 'type': 'RESULT', 'citation': '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': '19467849', 'type': 'RESULT', 'citation': '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': '25742321', 'type': 'RESULT', 'citation': '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': '25866645', 'type': 'RESULT', 'citation': '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': '25918120', 'type': 'RESULT', 'citation': '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': '21103404', 'type': 'RESULT', 'citation': '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': '9789243', 'type': 'RESULT', 'citation': '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': '16936234', 'type': 'RESULT', 'citation': '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': '1759018', 'type': 'RESULT', 'citation': "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': '25359355', 'type': 'RESULT', 'citation': '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': '17197484', 'type': 'RESULT', 'citation': "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': '26797036', 'type': 'RESULT', 'citation': "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': '15764761', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://goldcopd.org/global-strategy-diagnosis-management-prevention-copd-2016/', 'label': 'Global initiative for Chronic Obstructive Lung Disease. Update 2016'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'Design: interventional, crossover, randomized.\n\nThe 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).\n\nPatients 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.\n\nIn total, each patient will be evaluated four times on four different visits. The testing order will be randomized through STATA.\n\nThe following variables will be measured before, during and after each test:\n\n1. Max speed reached in an Incremental load test: Km/h\n2. Max time tolerate in a Constant Load Test: in seconds\n3. Oxygen saturation: %\n4. Dyspnea: Modified Borg scale (0-10)\n5. Cardiac rate: beats per minute\n6. Respiratory rate: breaths per minute\n7. Blood pressure: mmHg\n8. Lower limbs fatigue: modified Borg scale (0-10)\n9. Global comfort according to the device used: visual analogue scale (VAS) 0-10'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Long term oxygen therapy (LTOT) or oxygen needs during exercise.\n* Clinically stable defined as four weeks without exacerbation.\n\nExclusion Criteria:\n\n* Refusal to participate\n* Any neuromuscular or cardiovascular or condition that limits test performance.\n* Contraindication for exercise'}, 'identificationModule': {'nctId': 'NCT02858960', 'briefTitle': 'High Flow Nasal Cannula and Exercise in Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'Comparing Exercise Capacity in Patients With COPD Using High Flow Nasal Cannula Oxygen vs The Venturi Mask', 'orgStudyIdInfo': {'id': '2719'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Flow Nasal Cannula Oxygen', 'description': '1. Incremental Load Treadmill Test (ILTT) using HFNCO\n2. Constant Treadmill Load Test (CTLT) using HFNCO', 'interventionNames': ['Device: High Flow Nasal Cannula Oxygen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The Venturi Mask', 'description': '1. Incremental Load Treadmill Test (ILTT) using venturi mask\n2. Constant Treadmill Load Test (CTLT) using venturi mask', 'interventionNames': ['Device: The Venturi Mask']}], 'interventions': [{'name': 'High Flow Nasal Cannula Oxygen', 'type': 'DEVICE', 'otherNames': ['HFNCO'], 'description': 'Exercise capacity testing according to High Flow Nasal Cannula Oxygen in COPD patients involved in a Pulmonary Rehabilitation program.', 'armGroupLabels': ['High Flow Nasal Cannula Oxygen']}, {'name': 'The Venturi Mask', 'type': 'DEVICE', 'description': 'Exercise capacity testing according to the oxygen Mask Venturi in COPD patients involved in a Pulmonary Rehabilitation program.', 'armGroupLabels': ['The Venturi Mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1181ACH', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Nicolas NR Roux, PT-RT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-02-06', 'type': 'RELEASE'}, {'date': '2018-10-01', 'type': 'RESET'}], 'unpostedResponsibleParty': "SILVINA DELL'ERA, PT-RT, Hospital Italiano de Buenos Aires"}}}}