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

Not Applicable

Completed

• Conditions: Topic: Metabolic and endocrine disorders, Respiratory disorders; Subtopic: Metabolic and Endocrine (all Subtopics), Respiratory (all Subtopics); Disease: Metabolic & Endocrine (not diabetes), Respiratory; Respiratory

• Registration Number: ISRCTN51420481
• Lead Sponsor: Guy's and St. Thomas' NHS Foundation Trust (UK)

Brief Summary

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25908673 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36342884/ (added 08/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-12
• Study Completion: 2018-04-30
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

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 <90%)
5. BMI>35kg/m2
6. FEV1/FVC>70%
7. Tolerates NIV>4 hours on first night during initiation of NIV

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified