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

COPD Clinical Trial

Official title:

Comparing Exercise Capacity in Patients With COPD Using High Flow Nasal Cannula Oxygen vs The Venturi Mask

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858960
• Other study ID #: 2719
• Status: Completed
• Phase: N/A
• First received: March 29, 2016
• Last updated: May 4, 2017
• Start date: April 2016
• Est. completion date: April 30, 2017

Study information

• Verified date: August 2016
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 two different oxygen delivery devices (High Flow Nasal Cannula Oxygen and The Mask Venturi).

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 HFNCO and the other time with The VM.

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:

1. Max speed reached in an Incremental load test: Km/h

2. Max time tolerate in a Constant Load Test: in seconds

3. Oxygen saturation: %

4. Dyspnea: Modified Borg scale (0-10)

5. Cardiac rate: beats per minute

6. Respiratory rate: breaths per minute

7. Blood pressure: mmHg

8. Lower limbs fatigue: modified Borg scale (0-10)

9. Global comfort according to the device used: visual analogue scale (VAS) 0-10

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Long term oxygen therapy (LTOT) or oxygen needs during exercise.

• Clinically stable defined as four weeks without exacerbation.

Exclusion Criteria:

• Refusal to participate

• Any neuromuscular or cardiovascular or condition that limits test performance.

• Contraindication for exercise

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• High Flow Nasal Cannula Oxygen
Exercise capacity testing according to High Flow Nasal Cannula Oxygen in COPD patients involved in a Pulmonary Rehabilitation program.
• The Venturi Mask
Exercise capacity testing according to the oxygen Mask Venturi in COPD patients involved in a Pulmonary Rehabilitation program.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (22)

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 A — View 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. — View 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. — View 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. Review. — View 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. — View 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 J — View Citation

Güell Rous MR, Díaz Lobato S, Rodríguez Trigo G, Morante Vélez F, San Miguel M, Cejudo P, Ortega Ruiz F, Muñoz A, Galdiz Iturri JB, García A, Servera E; Sociedad Española de Neumología y Cirugía Torácica (SEPAR).. Pulmonary rehabilitation. Sociedad Españo — View 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. — View 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 o — View Citation

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Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigaré 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, Tro — View Citation

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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. Review. — View 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;(2):CD005372. Review. — View 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. — View 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. — View 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 — View Citation

Rabinovich RA, Vilaró 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. Review. — View Citation

Sívori M, Almeida M, Benzo R, Boim C, Brassesco M, Callejas O, Capparelli I, Conti E, Díaz 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 argent — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Global initiative for Chronic Obstructive Lung Disease. Update 2016