Effect of portable NIV on operational chest wall volumes in COPD

  • Research type

    Research Study

  • Full title

    Effect of the VitaBreath device on chest wall dynamic hyperinflation and respiratory muscle activation during recovery from exercise in patients with Chronic Obstructive Pulmonary Disease.

  • IRAS ID

    259201

  • Contact name

    Stephen Bourke

  • Contact email

    stephen.bourke@NHCT.nhs.uk

  • Sponsor organisation

    Northumbria Healthcare NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT03848819

  • Clinicaltrials.gov Identifier

    Clinicaltrial.gov, NCT03848819

  • Duration of Study in the UK

    0 years, 7 months, 20 days

  • Research summary

    People with COPD have difficulty breathing out fully, thus they breath at higher lung volumes than other people. Breathing at higher lung volumes requires more effort. When anyone exercises, they breathe more quickly. People with COPD have narrowed airways and during rapid breathing they may not be able to breathe out fully before taking the next breath in. This means that the volume of air trapped in their lungs increases further during exercise, making breathing even more difficult. This problem is called “dynamic hyperinflation”.

    Non-invasive ventilation supports a person’s normal breathing. The ventilator delivers a flow of air at low pressure as you breathe out, which helps COPD patients to breathe out more completely. The device also helps patients take a deeper breath in by delivering a stronger flow of air at higher pressure. The VitaBreath device is a small light battery powered non-invasive ventilator, designed for intermittent use to relieve breathlessness.

    In a previous study (REC:17/NE/0085) we showed that use of the VitaBreath device during recovery periods between bouts of exercise improved exercise tolerance and breathlessness, probably due to more rapid recovery from exercised induced dynamic hyperinflation. We were only able to assess lung volumes at two time points by measurement of the volume of air patients could breathe in after a breath out. Further limitations of this technique include the requirement to breathe through a spirometer and difficulty performing the test.

    Optoelectronic plethysmography (OEP) uses reflective markers attached to the patient’s torso and 8 cameras to map the volume of the chest and upper abdomen breath-by-breath. We will use OEP to assess recovery from exercise induced hyperinflation using the VitaBreath device compared to pursed-lip-breathing (a normal adaptation in COPD patients). We will also assess muscle electrical signals and oxygenation non-invasively to assess breathing muscle activity and energy demands.

  • REC name

    North East - Newcastle & North Tyneside 1 Research Ethics Committee

  • REC reference

    19/NE/0091

  • Date of REC Opinion

    22 May 2019

  • REC opinion

    Further Information Favourable Opinion