Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Use of Ventilator Monitoring for Early Detection of Exacerbations of Chronic Lung Disease
The aim of this study is to determine whether respiratory disease exacerbations (a sudden
worsening of symptoms) can be predicted by variables that are monitored by non-invasive
ventilators (small machines that assist breathing) in patients requiring long term home
ventilation.
The investigators hypothesise that acute exacerbations of patients with respiratory disease
and ventilatory failure will be predicted by changes in the respiratory variables monitored
and stored by ventilators during chronic home ventilator use.
This pilot study is a proof of concept study investigating whether respiratory variables
measured during chronic non-invasive ventilation (NIV) therapy may be used to predict a
disease exacerbation.
Modern ventilators used in the home for chronic respiratory failure have the ability to
monitor and store respiratory variables that may worsen during exacerbations, and may
potentially detect exacerbations before symptoms become apparent. Normal pressure support
ventilators monitor respiratory rate which might be expected to increase with worsening
disease. In patients with obstructive airways disease an increase in expiratory time may
potentially be observed with worsening airways obstruction. Adaptive servo ventilators,
which modulate pressure support to maintain constant minute ventilation, may increase the
amount of pressure support delivered if respiratory mechanics deteriorate as a result of an
exacerbation.
Consenting experienced NIV users will be switched to an adaptive-servo ventilator with the
capacity to monitor and store therapy data. The device being used is the Stellar 150
ventilator (Resmed, Ltd., Bella Vista, Australia) with hardware and software ability to
measure variables such as respiratory rate, airflow, pressure support and leak.
Patients will use the ventilator for a total of 4 months during which they will complete
daily symptom diaries, including medication use and peak flow measurements.
Changes in ventilator variables will be analysed and day to day variation identified.
Changes will be compared with daily peak expiratory flow measures (an indication of how well
the airways are functioning), patient symptoms, and healthcare utilization. Hospital
admissions for exacerbations, GP consults, and healthcare team contacts will also be
measured.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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