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

COPD Clinical Trial

Official title:

Exercise Capacity Testing in COPD Patients With High Flow Nasal Cannula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860273
• Other study ID #: 2728
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study the investigators will determine whether the use of High Flow Nasal Cannula Oxygen during test enhances exercise performance in COPD patients on a treadmill.

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 High Flow Nasal Cannula Oxygen (HFNCO).

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 High Flow Nasal Cannula Oxygen and the other breathing room air.

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:

Max speed reached in an Incremental load test: Km/h Max time tolerate in a Constant Load Test: in seconds Oxygen saturation: % Dyspnea: Modified Borg scale (0-10) Cardiac rate: beats per minute Respiratory rate: breaths per minute Blood pressure: mmHg Lower limbs fatigue: modified Borg scale (0-10) Global comfort according to the device used: visual analogue scale (VAS) 0-10

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinically stable defined as four weeks without exacerbation.

• Signed Informed consent

Exclusion Criteria:

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

• Any neuromuscular or cardiovascular condition that limits test performance

• Refusal to participate

• Contraindication for exercise

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• High Flow Nasal Cannula Oxygen
Exercise capacity testing according to High Flow Nasal Cannula Oxygen at 21% in COPD patients involved in a Pulmonary Rehabilitation program.
• Treadmill
Exercise capacity testing 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 (25)

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 Ap — 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. doi: 10.1378/chest.127.3.809. — 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. doi: 10.2147/copd.s11153. — 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. — 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

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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, 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, 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. — View Citation

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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. — View Citation

O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122. — View Citation

O'Donnell DE. Hyperinflation, dyspnea, and exercise intolerance in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2006 Apr;3(2):180-4. doi: 10.1513/pats.200508-093DO. — 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. doi: 10.1378/chest.101.5_supplement.274s. — 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, 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. — View 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 argent — View 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. — 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

van 't Hul A, Kwakkel G, Gosselink R. The acute effects of noninvasive ventilatory support during exercise on exercise endurance and dyspnea in patients with chronic obstructive pulmonary disease: a systematic review. J Cardiopulm Rehabil. 2002 Jul-Aug;22 — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Exercise capacity - Maximun Walking Time Tolerated	Difference in Maximun Walking time tolerated in a Constant Treadmill Load Test (CTLT) in seconds between HFNCO and Room air	Baseline and 48 hs after baseline
Secondary	Difference in Dyspnea	Difference in dyspnea using Modified Borg Scale (0 - 10 points) between HFNCO and Room air	Baseline and 48 hs after baseline
Secondary	Difference in Cardiac Rate	Difference in Cardiac Rate (beats per minute) using a pulse oximetry between HFNCO and Room air	Baseline and 48 hs after baseline
Secondary	Difference in Oxygen Saturation	Difference in Oxygen Saturation using a pulse oximetry (SpO2) between HFNCO and Room air	Baseline and 48 hs after baseline
Secondary	Difference in Global Comfort	Difference in global comfort according to the device used with visual analogue scale (VAS) 0-10 between HFNCO and Room air	Baseline and 48 hs after baseline
Secondary	Difference in Lower Limbs Fatigue	Difference in Lower limbs fatigue using modified Borg scale (0-10) between HFNCO and Room air	Baseline and 48 hs after baseline
Secondary	Difference in Respiratory Rate	Difference in Respiratory rate in breaths per minute between HFNCO and Room air	Baseline and 48 hs after baseline
Secondary	Difference in Blood Pressure	Difference in of Blood pressure in mmHg between HFNCO and Room air	Baseline and 48 hs after baseline
Secondary	Difference in Exercise capacity - Maximun Walking Speed Reached	Difference in Maximun walking speed in km/h reached in an Incremental load treadmill test (ILTT) between HFNCO and Room air	Baseline and 48 hs after baseline

External Links

•   Global initiative for Chronic Obstructive Lung Disease. Update 2016