Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Medium Cost Effectiveness of Automated Non-Invasive Ventilation Outpatient Set Up vs Standard Fixed Level Non-Invasive Ventilation Inpatient Set Up In Obese Patients With Chronic Respiratory Failure
Brief Summary:
Obesity is an escalating issue, with an accompanying increase in referrals of patients with obesity-related respiratory failure. Currently, these patients are electively admitted to hospital for initiation of non-invasive ventilation (NIV), but it is unknown whether outpatient initiation is as effective as inpatient set-up. The investigators hypothesise that outpatient set up using an auto-titrating NIV device will be more cost effective than nurse-led inpatient titration and set-up.
The investigators will undertake a multi-national, multi-centre randomised controlled trial.
Subjects will be randomised to receiving usual inpatient set-up, which will include nurse-led initiation of NIV or outpatient set-up with an automated NIV device. Subjects will be stratified according to trial site, gender and previous use of NIV or continuous positive airway pressure. Assuming 10% drop out rate, a total sample of 82 patients will be required. Cost effectiveness will be evaluated using standard treatment costs and health service utilisation and using health related quality of life measures (SRI and EQ5D). Change in the severe respiratory insufficiency (SRI) questionnaire will be based on analysis of covariance (ANCOVA) adjusting for the baseline measurements between the two arms of patients.