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 disease: a randomised controlled trial

Guy's and St. Thomas' NHS Foundation Trust (UK)0 个研究点目标入组 82 人开始时间: 2014年6月12日最近更新: 2022年11月21日

试验速览

•1. Obese patients with chronic respiratory failure
•2. Age >18 years
•3. Chronic hypercapnia (daytime pCO2>6.5kPa)
•4. Evidence of sleep disordered breathing on overnight oximetry study (4% oxygen desaturation index>10 events per hour and/or >30% of the total analysis time with an SpO2 <90%)
•5. BMI>35kg/m2
•6. FEV1/FVC>70%
•7. Tolerates NIV>4 hours on first night during initiation of NIV

•1. Persistent hypercapnic respiratory failure with acidosis (defined as pH <7.30)
•2. Severe hypoxic and/or hypercapnic respiratory failure defined as PaO2<7.0kPa and/or PaCO2>9kPa
•3. Failure to tolerate NIV during initiation or if required to treat acute decompensation
•4. Prior acute hypercapnic respiratory failure requiring intubation
•5. Hypercapnic respiratory failure secondary to an identifiable cause other than obesity
•6. Unstable coronary artery syndrome
•7. Cognitive impairment that would prevent informed consent into the trial and/or inability to comply with the protocol
•8. Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge
•9. Patients undergoing renal replacement therapy
•10. Patients with co-existent cancer and a prognosis likely to be less than 12-months
•11. Critical peripheral vascular disease awaiting re-vascularisation procedure (or claudication distance <100 metres)
•12. Stroke with hemiparesis
•13. Age <18 years
•14. Pregnant

发起方

Guy's and St. Thomas' NHS Foundation Trust (UK)