Obesity Hypoventilation Syndrome Clinical Trial
— OPIPOfficial 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
Verified date | February 2020 |
Source | Guy's and St Thomas' NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | October 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Obese patients with chronic respiratory failure - Age > 18 years - Chronic hypercapnia (daytime PaCO2 > 6.0kPa) - Evidence of sleep disordered breathing on overnight oximetry study (4% oxygen desaturation index >10events per hour and/or >30% of the total analysis time with an SpO2 < 90%) - Patients with a recent acute episode requiring non-invasive ventilation will need a minimum of 2 weeks stability prior to enrolment into the trial (no NIV requirement for 2 weeks and pH (Inverse logarithm of hydrogen ion concentration) = 7.3) - BMI = 35kg/m2 - FEV1/FVC (Forced Expiratory Volume at 1 second/Forced Vital Capacity) > 70% Exclusion Criteria: - Persistent hypercapnic respiratory acidosis defined as pH <7.30 - Severe hypoxic and/or hypercapnic respiratory failure defined as a PaO2 (Partial Pressure of Oxygen)< 7.0kPa and/or a PaCO2 > 9kPa (kilopascal) - Failure to tolerate NIV during initiation or if required to treat acute decompensation - Hypercapnic respiratory failure requiring intubation within the last 28 days - Hypercapnic respiratory failure secondary to an identifiable cause other than obesity - Acute coronary syndrome or unstable angina - Cognitive impairment that would prevent informed consent into the trial and/or inability to comply with the protocol - Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge - Patients undergoing renal replacement therapy - Patients with co-existent cancer and a prognosis likely to be less than 12-months - Critical peripheral vascular disease awaiting re-vascularisation procedure (or claudication distance <100 metres) - Stroke with hemiparesis - Age <18 years - Pregnant |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Universitaire, de Grenoble | Grenoble | |
France | Rouen University Hospital | Rouen | |
United Kingdom | Leeds Teaching Hospital NHS Foundation Trust | Leeds | Yorkshire |
United Kingdom | Guys and St Thomas NHS Foundation | London | |
United Kingdom | Royal Brompton and Harefield NHS Foundation Trust | London | |
United Kingdom | Royal Free Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust | Philips Research |
France, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Medium Term Cost-Effectiveness | 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 | 3 months | |
Secondary | Health Related Quality of Life | To evaluate the health related quality of life improvements between outpatient non-invasive ventilation set-up and inpatient set-up at 3 months | 3 months | |
Secondary | Gas Exchange Improvements | To evaluate the gas exchange improvements between outpatient non-invasive ventilation set-up and inpatient set-up at 3 months. | 3 months |
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