Obesity Hypoventilation Syndrome Clinical Trial
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
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.
There is an increase of patients with hypercapnic respiratory failure as a consequence of
obesity. The current treatment options for patients with obesity related respiratory failure
is non-invasive ventilation (NIV). This has shown to reduce partial pressure of arterial
carbon dioxide (PaCO2) and improves symptoms such as dyspnea (breathlessness)and enhances
quality of life. NIV has also shown to increase physical activity (using actigraphy)and there
can be associated weight reduction after three months of initiation.
Currently, the length of an inpatient stay for NIV set up is between 4.5 and 6 days. As yet
it is unknown whether or not a patient can be set up onto NIV as effectively on an outpatient
basis using an AE-AVAPS (Automatic Expiratory Positive Airway Pressure - Average Volume
Assured Pressure Support) algorithm compared to the usual practice of inpatient titration by
specialist respiratory nurses. Furthermore, the cost effectiveness of outpatient initiation
vs inpatient initiation is unknown in this group of patients.
This will be the first trial to assess the cost effectiveness of such a set up.
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