Last updated on February 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pickwickian Syndrome | Chronic Respiratory Failure
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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