Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Randomised Controlled Trial of Home Mechanical Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease Patients Post Acute Hypercapnic Exacerbation
This study is designed to investigate the effect of home mechanical ventilation (HMV) in patients with severe chronic obstructive pulmonary disease (COPD). The purpose of the trial is to test the hypothesis that HMV and longterm oxygen therapy (LTOT) increases admission free survival compared with LTOT alone. More specifically, compared with LTOT, HMV and LTOT reduces hospital re-admission in COPD patients who remain persistently hypercapnic following an acute exacerbation requiring non-invasive ventilation (NIV).
Although HMV has been shown to improve physiological parameters as well as have clinical
benefits in terms of dyspnoea and exercise capacity in severe COPD, the published randomised
controlled trials have been less positive. The Steering Committee are committed to design a
robust clinical trial that will answer this clinical question. Therefore, a multi-centre
randomised controlled trial has been designed with recruitment and power calculations based
on the applicants own data.
We will recruit from 8 UK university centres with expertise in HMV, 116 hypercapnic patients
(58 in each arm) with persistent hypercapnia following an episode of acute hypercapnic
respiratory failure. During the acute hypercapnic episode the patient would have be eligible
for non-invasive ventilation with a pH <7.35 and a partial pressure of carbon dioxide
(PaCO2) > 7.0kPa. They will be randomised, for a 12 months, to either
1. HMV and LTOT (Treatment Group)
2. LTOT alone (Control Group) This study would allow the investigators to answer a number
of questions pertaining to clinical efficacy of HMV in COPD as well as the mechanism of
action of HMV in COPD
- Does HMV effect admission-free survival?
- Does HMV reduce exacerbation frequency?
- Does HMV impact on disease progression?
- Does HMV improve health-related quality of life?
- Does HMV improve exercise capacity?
- Is there a dose-response between hours of ventilator compliance and daytime PaO2
and PaCO2?
- Do patients increase hours of ventilator use during acute exacerbations?
- Is ventilator compliance with HMV and LTOT acceptable?
- Does HMV reduce healthcare utilisation? Follow-up assessments will be performed at
6 weeks, 3, 6 and 12 months. These data collected will include admission-free
survival (primary outcome), hours of compliance with HMV, HRQL, gas exchange, lung
function, body composition, exercise capacity, exacerbation frequency primary care
consultations and compliance with LTOT, time to withdrawal of LTOT/night-time
oxygen therapy based on daytime PaO2 and overnight SaO2 (secondary outcome
measures). The relation of any changes to factors predicting severity of COPD will
be studied. The cost effectiveness and cost-utility analysis of HMV will be
studied.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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