COPDNCT02973945
High Flow Nasal Cannula and Aerobic Capacity Training
A study testing High Flow Nasal Cannula and The Venturi Mask in people with COPD, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COPD
- What is being tested?
- High Flow Nasal Cannula and The Venturi Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jul 2017to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Long term oxygen therapy (LTOT) or oxygen needs during exercise.
- Clinically stable defined as four weeks without exacerbation
Who cannot join
- Refusal to participate
- Any neuromuscular, cardiovascular or any other condition that limits test performance.
- Contraindication for exercise
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos AIres
Buenos Aires, C1181ACH
About this study
Official title: 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)
Read the 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).
- Conditions
- COPD
- Being tested
- High Flow Nasal Cannula, The Venturi Mask
- Keywords
- Pulmonary Rehabilitation, High Flow Nasal Cannula, The Venturi Mask, Exercise capacity, Aerobic capacity, HFNC
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal CannulaDevice
Also called HFNC
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.
The Venturi MaskDevice
Also called VM
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.
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula | Experimental | 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. Receives: Device: High Flow Nasal Cannula |
| The Venturi Mask | Active comparator | 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. Receives: Device: The Venturi Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 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.
This CLTT will be performed three times, always after an Incremental Load Treadmill Test (ILTT)
Measured: 8 weeks
Secondary outcomes (6)
Six Minutes Walking Test
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.
Measured: 8 weeks
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 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)
Measured: 8 weeks
Quality of Life - The St George's Respiratory Questionnaire
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.
Measured: 8 weeks
Quality of Life -Chronic Obstructive Pulmonary Disease Assessment Test
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.
Measured: 8 weeks
Dyspnea
The modified Medical research Council Scale (0-4) will be used in order to assess the breathless subjective sensation.
Measured: 8 weeks
Comfort
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study start1 Jul 2017
- Primary completionMar 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas NR Roux, PT-RT, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973945
- Sponsor's protocol ID
- 3011
- Status last verified
- May 2017
- First submitted
- 10 Nov 2016
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 20071991Maltais 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.
PubMed 24787074Spruit 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.
PubMed 24127811Guell 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.
PubMed 24845559Sivori 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.
PubMed 18786894O'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.
PubMed 11282762Maltais F, Simon M, Jobin J, Desmeules M, Sullivan MJ, Belanger M, Leblanc P. Effects of oxygen on lower limb blood flow and O2 uptake during exercise in COPD. Med Sci Sports Exerc. 2001 Jun;33(6):916-22. doi: 10.1097/00005768-200106000-00010.
PubMed 11404656Frat 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.
PubMed 25981908Nishimura 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.
PubMed 25866645Cirio S, Piran M, Vitacca M, Piaggi G, Ceriana P, Prazzoli M, Paneroni M, Carlucci A. Effects of heated and humidified high flow gases during high-intensity constant-load exercise on severe COPD patients with ventilatory limitation. Respir Med. 2016 Sep;118:128-132. doi: 10.1016/j.rmed.2016.08.004. Epub 2016 Aug 8.
PubMed 27578482Hardinge 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.
PubMed 25918120Puente-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.
PubMed 26797036Cooper 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.
PubMed 21103404Marrugat 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.
PubMed 9789243ERS 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.
PubMed 17197484
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Versus The Venturi Mask During Exercise Training in Chronic Obstructive Pulmonary Disease Patients, a Randomized, Simple Blind, Controlled Trial.
- ClinicalTrials.gov ID
- NCT02973945
- Acronym / sponsor ID
- 3011
- Conditions
- COPD
- Keywords
- Pulmonary Rehabilitation, High Flow Nasal Cannula, The Venturi Mask, Exercise capacity, Aerobic capacity, HFNC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula | Experimental | Device: High Flow Nasal CannulaDuring 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. |
| The Venturi Mask | Active comparator | Device: The Venturi MaskDuring a 8 week Pulmonary Rehabilitation Program patients will receive oxygen through The Venturi Mask (VM) while they are training aerobic capacity on the treadmill. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Long term oxygen therapy (LTOT) or oxygen needs during exercise.
- Clinically stable defined as four weeks without exacerbation
Key exclusion criteria (3 listed)
- Refusal to participate
- Any neuromuscular, cardiovascular or any other condition that limits test performance.
- Contraindication for exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow Nasal CannulaAlso: HFNCDuring 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. | Device | High Flow Nasal Cannula |
| The Venturi MaskAlso: VMDuring 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. | Device | The Venturi Mask |
Primary outcome
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)
6 secondary outcomes
Six Minutes Walking Test
Time frame: 8 weeks
Exercise capacity - Maximum Walking Speed Reached
Time frame: 8 weeks
Quality of Life - The St George's Respiratory Questionnaire
Time frame: 8 weeks
Quality of Life -Chronic Obstructive Pulmonary Disease Assessment Test
Time frame: 8 weeks
Dyspnea
Time frame: 8 weeks
Comfort
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Results publication: PubMed 20071991Rabinovich 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.
- Results publication: PubMed 24787074Maltais 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.
- Results publication: PubMed 24127811Spruit 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.
- Results publication: PubMed 24845559Guell 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.
- Results publication: PubMed 18786894Sivori 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.
- Results publication: PubMed 11282762O'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.
- Results publication: PubMed 11404656Maltais F, Simon M, Jobin J, Desmeules M, Sullivan MJ, Belanger M, Leblanc P. Effects of oxygen on lower limb blood flow and O2 uptake during exercise in COPD. Med Sci Sports Exerc. 2001 Jun;33(6):916-22. doi: 10.1097/00005768-200106000-00010.
- Results publication: PubMed 25981908Frat 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.
- Results publication: PubMed 25866645Nishimura 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.
- Results publication: PubMed 27578482Cirio S, Piran M, Vitacca M, Piaggi G, Ceriana P, Prazzoli M, Paneroni M, Carlucci A. Effects of heated and humidified high flow gases during high-intensity constant-load exercise on severe COPD patients with ventilatory limitation. Respir Med. 2016 Sep;118:128-132. doi: 10.1016/j.rmed.2016.08.004. Epub 2016 Aug 8.
- Results publication: PubMed 25918120Hardinge 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.
- Results publication: PubMed 26797036Puente-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.
- Global initiative for Chronic Obstructive Lung Disease. Update 2016Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas NR Roux, PT-RT principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula and The Venturi Mask in people with COPD, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas NR Roux, PT-RT (+5411 4959 0200 ext. 9814, nicolas.roux@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exercise Capacity - Maximum Walking Time Reached (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02973945, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.