High Flow Nasal Cannula and Aerobic Capacity Training

COPD Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02973945
• Other study ID #: 3011
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2016
• Last updated: November 16, 2017
• Start date: July 1, 2017
• Est. completion date: May 2019

Study information

• Verified date: May 2017
• Source: Hospital Italiano de Buenos Aires
• Contact: Nicolas NR Roux, PT-RT
• Phone: +5411 4959 0200
• Email: nicolas.roux[@]hospitalitaliano.org.ar
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Mask (VM)

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

2. Clinically stable defined as four weeks without exacerbation

Exclusion Criteria:

1. Refusal to participate

2. Any neuromuscular, cardiovascular or any other condition that limits test performance.

3. Contraindication for exercise

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• High Flow Nasal Cannula
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 Mask
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.

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 (19)

Cirio 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;1 — 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

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 Español — 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

Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509. — View 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. — View Citation

Laszlo G. Standardisation of lung function testing: helpful guidance from the ATS/ERS Task Force. Thorax. 2006 Sep;61(9):744-6. — View Citation

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

Maltais F, Simon M, Jobin J, Desmeules M, Sullivan MJ, Bélanger 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. — View 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. Spanish. — View 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. 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

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

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 — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	8 weeks
Secondary	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.	8 weeks
Secondary	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)	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	Dyspnea	The modified Medical research Council Scale (0-4) will be used in order to assess the breathless subjective sensation.	8 weeks
Secondary	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	8 weeks

External Links

•   CAT - COPD Assessment Test
•   Global initiative for Chronic Obstructive Lung Disease. Update 2016