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

PHASE3CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

March 1, 2015

Primary Completion Date

June 30, 2018

Study Completion Date

October 30, 2018

Conditions
Obesity Hypoventilation SyndromeChronic 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.

Trial Locations (6)

76000

Rouen University Hospital, Rouen

Cedex 9

Hôpital Universitaire, de Grenoble, Grenoble

LS2 9LN

Leeds Teaching Hospital NHS Foundation Trust, Leeds

NW3 2QG

Royal Free Hospital, London

SE1 7EH

Guys and St Thomas NHS Foundation, London

SW3 6NP

Royal Brompton and Harefield NHS Foundation Trust, London

All Listed Sponsors
collaborator

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

INDUSTRY

lead

Guy's and St Thomas' NHS Foundation Trust

OTHER

NCT02342899 - Cost Effectiveness of Outpatient Set-up of Automated NIV in Obese Patients With Chronic Respiratory Failure | Biotech Hunter | Biotech Hunter