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

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.

Conditions

• Obesity Hypoventilation Syndrome
• Chronic Respiratory Failure

Interventions

DEVICE

Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics)

Intervention set ups will follow a standard protocol for the automated device (A40 AVAPS-AE machine;Manufactured by Philips-Respironics, Murraysville, Pittsburgh, US) and patients will be discharged with the machine and a full face mask or nasal interface. Patients will then undergo a 1-2 night home oximetry study to ensure adequate control of overnight oxygenation. Patients will be reviewed clinically as an outpatient at 6 weeks and adherence to non-invasive ventilation will be evaluated and an arterial blood gas measurement will be undertaken. A full clinical review and optimisation of NIV and interface will be performed at this visit. Patients will be reviewed at 3 months as an inpatient where overnight transcutaneous carbon dioxide level and SpO2 studies will be performed. All other patient-centred, physician-centred and healthcare utilisation measurements will be assessed at baseline, 6 weeks and 3 months.

DEVICE

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

The patient will follow a specialist nurse-led protocolised set up of spontaneous/timed (S/T) mode pressure support ventilation (A40 AVAPS-AE machine; Manufactured by Philips-Respironics, Murraysville, Pittsburgh, US) using limited respiratory polygraphy, including overnight TcCO2 (Trascutaneous Carbon Dioxide) and SpO2 (Oxygen Saturation) studies. Following the inpatient set-up, patients will be reviewed as an outpatient at 6 weeks and adherence with non-invasive ventilation will be evaluated and arterial blood gas measurements will be performed. Patients will then be reviewed at 3 months as an inpatient where overnight respiratory polygraphy, TcCO2 and SpO2 studies will be repeated. All other patient-centred, physician-centred measurements and healthcare utilisation measurements will be assessed at baseline, 6 weeks and 3 months.

Sponsors & Collaborators

• Philips Electronics Nederland B.V. acting through Philips CTO organization

  collaborator INDUSTRY

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• Nick Hart · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-01

Primary Completion

2018-06-30

Completion

2018-10-30

Countries

• France
• United Kingdom

Study Locations