Clinical Trial: Cost Effectiveness of Outpatient Set-up of Automated NIV in Obese Patients With Chronic Respiratory Failure

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.


Detailed Summary:

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.


Sponsor: Guy's and St Thomas' NHS Foundation Trust

Current Primary Outcome: Medium Term Cost-Effectiveness [ Time Frame: 3 months ]

To evaluate the medium term cost effectiveness of outpatient non-invasive ventilation set-up with an automated device compared with inpatient nurse-led protocolised fixed level non-invasive ventilation set-up in obese patients with chronic respiratory failure at 3 months


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Health Related Quality of Life [ Time Frame: 3 months ]
    To evaluate the health related quality of life improvements between outpatient non-invasive ventilation set-up and inpatient set-up at 3 months
  • Gas Exchange Improvements [ Time Frame: 3 months ]
    To evaluate the gas exchange improvements between outpatient non-invasive ventilation set-up and inpatient set-up at 3 months.


Original Secondary Outcome: Same as current

Information By: Guy's and St Thomas' NHS Foundation Trust

Dates:
Date Received: January 13, 2015
Date Started: March 2015
Date Completion: April 2018
Last Updated: November 24, 2016
Last Verified: November 2016