Effect of Portable NIV on Operational Chest Wall Volumes in COPD

NCT03848819 | Completed

• 1 other identifier: 259201
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown to reduce activity-related shortness of breath in patients with COPD. The VitaBreath device delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods. A previous study (REC: 17/NE/0085) showed that use of the VitaBreath device during the recovery periods interspersing successive exercise bouts enhances exercise tolerance and reduces breathlessness compared to pursed lip breathing in patients with COPD. This was attributed to faster recovery from exercise-induced dynamic hyperinflation, assessed by volitional inspiratory capacity manoeuvres using a spirometer. However, inspiratory capacity manoeuvres are effort dependent, thus limiting the number of repetitions the patient can perform during exercise. In addition, investigation of the direct effect of the application of the VitaBreath device on dynamic hyperinflation was not possible due to the need to employ a spirometer for assessing inspiratory capacity. Optoelectronic plethysmography (OEP) allows continuous non-invasive assessment of end-inspiratory and end-expiratory volumes of the thoracoabdominal wall and its compartments, thereby facilitating assessment of dynamic hyperinflation on a breath-by-breath basis without the necessity to breathe via a spirometer. Unfortunately, OEP technology was not available at the time of our previous study. The investigators will use OEP to provide accurate breath-by-breath volume measurements during exercise and recovery to evaluate whether the VitaBreath device reduces total and compartmental thoracoabdominal wall volumes compared to the pursed lip breathing technique. Furthermore, the investigators will investigate the effect of use of the VitaBreath device on respiratory muscle activation and respiratory muscle oxygenation using OEP technology in conjunction with electromyography (EMG) and near inferred spectroscopy (NIRS), respectively to appreciate how the application of the VitaBreath device impacts on the operation and energy demands of the respiratory muscles as compared to control pursed lip breathing. The investigators hypothesised that the use of the VitaBreath device during the recovery periods interspersing successive exercise bouts will reduce the magnitude of dynamic hyperinflation in a greater extent compared to the pursed lip breathing technique.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Dynamic Hyperinflation

Outcome Measures

Primary Outcomes (1)

• The magnitude of change in thoracoabdominal wall dynamic hyperinflation.

  Change from baseline in litres of thoracoabdominal wall volume at end of exercise and recovery from exercise from resting breathing.

  The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 1 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.

Secondary Outcomes (4)

• Compartmental thoracoabdominal wall volumes (rib cage and abdominal volumes) assessed by OEP.

  The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 2 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.

• Electromyographic activation (expressed as fractions of peak activation and in absolute terms in mV) assessed by surface electromyography

  The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 3 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.

• Respiratory muscle oxygenation requirements recorded from the intercostal and abdominal muscles by near infrared spectroscopy including measurements of: total haemoglobin (TOI), oxygenated haemoglobin (HbO2) and deoxygenated haemoglobin (HHb).

  The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 4 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.

• Cardiac output responses assessed non-invasively by cardio impedance technology

  The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 5 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.

Study Arms (2)

Control pursed lip breathing

OTHER

Patients will undergo one intermittent exercise protocols on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min recovery periods in between work bouts. During the 1st min of each recovery period patients will breathe adopting the pursed lip breathing technique. During the 2nd min of each recovery period patients will breathe normally. Patients will also score the intensity of their perceived dyspnoea using the Borg 1-10 scale. Cardiac output and stroke volume will be measured non-invasively using a cardio-impedance method (physio-flow) throughout the exercise and recovery periods. Respiratory muscle activation (EMG) and local respiratory muscle oxygen tissue oxygenation (NIRS) will be continuously recorded non-invasively using optodes placed on the skin throughout the exercise and recovery periods. In addition, arterial oxygen saturation will be recorded throughout the exercise and recovery periods using a pulse oximeter.

Device: VitaBreath device

pNIV

EXPERIMENTAL

Patients will undergo one intermittent exercise protocols on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min recovery periods in between work bouts. During the 1st min of each recovery period patients will breathe via the VitaBreath device. During the 2nd min of each recovery period patients will breathe normally. Patients will also score the intensity of their perceived dyspnoea using the Borg 1-10 scale. Cardiac output and stroke volume will be measured non-invasively using a cardio-impedance method (physio-flow) throughout the exercise and recovery periods. Respiratory muscle activation (EMG) and local respiratory muscle oxygen tissue oxygenation (NIRS) will be continuously recorded non-invasively using optodes placed on the skin throughout the exercise and recovery periods. In addition, arterial oxygen saturation will be recorded throughout the exercise and recovery periods using a pulse oximeter.

Device: VitaBreath device

Interventions

VitaBreath device DEVICE

The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown by our group to reduce activity-related shortness of breath in patients with COPD. It delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods. In our study patients will perform consecutive bouts of exercise alternated by two minute of recovery in order to allow the use of the VitaBreath device during the first minute of each recovery period.

Control pursed lip breathing; pNIV

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 40 years or older.
• Current or previous smoking history: 10 or more pack years.
• Spirometry confirmed stable COPD (GOLD stages II-IV) under optimal medical therapy.
• Exhibit substantial exercise-induced dynamic hyperinflation (ΔIC baseline \> 0,150 L)

You may not qualify if:

• Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator.
• Moderate or severe COPD exacerbation within 6 weeks.
• Unstable cardiac arrhythmia.
• Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.
• Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.
• Uncontrolled hypertension.
• Uncontrolled hypotension (SBP\<85mmHg).
• Uncontrolled diabetes.
• Intolerance of the VitaBreath device.

Sponsors & Collaborators

• Northumbria University: lead
• North Tyneside General Hospital: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

Related Publications (12)

• 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.

  PMID: 11549531 BACKGROUND

• 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: 24787074 BACKGROUND

• Vogiatzis I, Zakynthinos S. Factors limiting exercise tolerance in chronic lung diseases. Compr Physiol. 2012 Jul;2(3):1779-817. doi: 10.1002/cphy.c110015.

  PMID: 23723024 BACKGROUND

• Beauchamp MK, Nonoyama M, Goldstein RS, Hill K, Dolmage TE, Mathur S, Brooks D. Interval versus continuous training in individuals with chronic obstructive pulmonary disease--a systematic review. Thorax. 2010 Feb;65(2):157-64. doi: 10.1136/thx.2009.123000. Epub 2009 Dec 8.

  PMID: 19996334 BACKGROUND

• Morris NR, Walsh J, Adams L, Alision J. Exercise training in COPD: What is it about intensity? Respirology. 2016 Oct;21(7):1185-92. doi: 10.1111/resp.12864.

  PMID: 27623321 BACKGROUND

• 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: 26797036 BACKGROUND

• Sabapathy S, Kingsley RA, Schneider DA, Adams L, Morris NR. Continuous and intermittent exercise responses in individuals with chronic obstructive pulmonary disease. Thorax. 2004 Dec;59(12):1026-31. doi: 10.1136/thx.2004.026617.

  PMID: 15563700 BACKGROUND

• 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: 11282762 BACKGROUND

• Palange P. Lighter than air: heliox breathing improves exercise tolerance in COPD. Eur Respir Rev. 2010 Mar;19(115):1-3. doi: 10.1183/09059180.00000210. No abstract available.

  PMID: 20956159 BACKGROUND

• Ambrosino N, Cigni P. Non invasive ventilation as an additional tool for exercise training. Multidiscip Respir Med. 2015 Apr 9;10(1):14. doi: 10.1186/s40248-015-0008-1. eCollection 2015.

  PMID: 25874110 BACKGROUND

• Vogiatzis I, Chynkiamis N, Armstrong M, Lane ND, Hartley T, Gray WK, Bourke SC. Intermittent Use of Portable NIV Increases Exercise Tolerance in COPD: A Randomised, Cross-Over Trial. J Clin Med. 2019 Jan 15;8(1):94. doi: 10.3390/jcm8010094.

  PMID: 30650617 BACKGROUND

• Vogiatzis I, Georgiadou O, Golemati S, Aliverti A, Kosmas E, Kastanakis E, Geladas N, Koutsoukou A, Nanas S, Zakynthinos S, Roussos C. Patterns of dynamic hyperinflation during exercise and recovery in patients with severe chronic obstructive pulmonary disease. Thorax. 2005 Sep;60(9):723-9. doi: 10.1136/thx.2004.039115. Epub 2005 Jun 17.

  PMID: 15964912 BACKGROUND

Related Links

• Philips white paper

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomised crossover trial. Patients will perform two identical exercise tests and the intervention (VitaBreath) will be compared to control condition (pursed-lip breathing) in the same patients.The order of testing will be determined by simple randomisation (sealedenvelope.com).

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 21, 2019
• Study Start: July 1, 2019
• Primary Completion: December 20, 2019
• Study Completion: February 29, 2020
• Last Updated: September 11, 2020

Record last verified: 2019-02

Locations

GB (1)