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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51420481

Enrollment

Registered

2014-06-12

Start date

2014-07-01

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Metabolic and endocrine disorders, Respiratory disorders

Interventions

A randomised controlled trial of Outpatient vs Inpatient NIV Set Up, randomised by site, gender and previous mask use, to determine clinical and cost effectiveness of outpatient set up. All patients w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 35kg/m2 6. FEV1/FVC>70% 7. Tolerates NIV>4 hours on first night during initiation of NIV

Exclusion criteria

Exclusion criteria: 1. Persistent hypercapnic respiratory failure with acidosis (defined as pH 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

Design outcomes

Primary

Measure	Time frame
Cost effectiveness of standard treatment costs and health related quality of life (SRI and Eq-5D); Timepoint(s): Baseline, 6 weeks and 3 months	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

England, France, Switzerland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026