NCT02342899: OPIP

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

Completed Phase 3 Last updated 7 February 2020

What this trial tests

Phase 3 trial testing Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics) in Obesity Hypoventilation Syndrome in 82 participants. Completed in 30 October 2018.

Timeline

1 March 2015

Primary endpoint
30 June 2018

30 October 2018

Quick facts

Lead sponsor	Guy's and St Thomas' NHS Foundation Trust
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	82
Start date	1 March 2015
Primary completion	30 June 2018
Estimated completion	30 October 2018
Sites	6 locations across France, United Kingdom

Drugs / interventions tested

• Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics)
• Inpatient NIV Set Up using spontaneous/timed (S/T) mode pressure support ventilation (Manufactured by Philips-Respironics)

Conditions studied

• Obesity Hypoventilation Syndrome — all drugs for Obesity Hypoventilation Syndrome →
• Chronic Respiratory Failure — all drugs for Chronic Respiratory Failure →

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Who can join

18 and older, any sex, with Obesity Hypoventilation Syndrome or Chronic Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cost-effectiveness of outpatient versus inpatient non-invasive ventilation setup in obesity hypoventilation syndrome: the OPIP trial.
   Murphy PB, Patout M, Arbane G, Mandal S, et al · · 2023 · cited 28× · PMID 36342884 · DOI 10.1136/thorax-2021-218497