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Nocturnal Non-Invasive Nasal Ventilation in Stable Hypercapnic COPD: A Randomised Controlled Trial
  1. R Douglas McEvoy (doug.mcevoy{at}health.sa.gov.au)
  1. Adelaide Institute for Sleep Health, Repatriation General Hospital, Australia
    1. Robert J Pierce (robert.pierce{at}austin.org.au)
    1. Institute for Breathing and Sleep, Austin Hospital, Heidelberg, Victoria 3081, Australia
      1. David Hillman (david.hillman{at}health.wa.gov.au)
      1. WA Sleep Disorders Research Institute, Queen Elizabeth II Medical Centre, Nedlands 6009, Australia
        1. Adrian Esterman (adrian.esterman{at}unisa.edu.au)
        1. School of Nursing and Midwifery, University of South Australia 5000, Australia
          1. E E Ellis (elizabethellis{at}ozemail.com.au)
          1. School of Physiotherapy, Faculty of health Sciences, University of Sydney 2006, Australia
            1. Peter G Catcheside (peter.catcheside{at}health.sa.gov.au)
            1. Adelaide Institute for Sleep Health, Repatriation General Hospital, Australia
              1. Fergal J O'Donoghue (fergal.o'donoghue{at}austin.org.au)
              1. Adelaide Institute for Sleep Health, Repatriation General Hospital, Australia
                1. David J Barnes (davidb{at}med.usyd.edu.au)
                1. Sleep Research Group, Woolcock Institute, Royal Prince Alfred Hospital and University, Sydney 2006, Australia
                  1. Ronald R Grunstein (rrg{at}med.usyd.edu.au)
                  1. Sleep Research Group, Woolcock Institute, Royal Prince Alfred Hospital and University, Sydney 2006, Australia

                    Abstract

                    Background: Sleep hypoventilation has been proposed as a cause of progressive hypercapnic respiratory failure and death in patients with severe chronic obstructive pulmonary disease (COPD).

                    Objective: To determine the effects of nocturnal, non-invasive bi-level pressure support ventilation (NIV) on survival, lung function and quality of life in severe hypercapnic COPD.

                    Design: A multicentre, open-label, randomized controlled trial of NIV plus long term oxygen therapy (LTOT) versus LTOT alone.

                    Setting: University Hospital sleep/ respiratory medicine departments.

                    Patients: Severe, stable, smoking-related COPD (FEV1.0 < 1.5 L or <50% predicted and FEV1.0/FVC <60% with awake PaCO2 > 46mmHg and on LTOT for at least 3 months) and age less than 80 years. Patients with sleep apnea (Apnea-hypopnea Index > 20/ hr) or morbid obesity (BMI >40) were excluded.

                    Intervention: Night-time bilevel pressure support ventilation.

                    Measurements: Survival, spirometry, arterial blood gases, polysomnography, general and disease specific quality of life, and mood.

                    Results: 144 patients were randomized: 72 to NIV + LTOT and 72 to LTOT alone. NIV improved sleep quality and sleep-related hypercapnia acutely, and patients complied well with therapy (mean nightly use 4.5 hours, SD 3.2 hours). Compared with LTOT alone, NIV (mean follow-up 2.21 years, range 0 – 5.59 years) resulted in a small improvement in survival (adjusted hazard ratio, 95% CI: 0.63, 0.40 – 0.99; p = 0.045). FEV1.0 and PaCO2 measured at 6 and 12 months were not different between groups. Patients assigned to NIV + LTOT had reduced general and mental health and vigor.

                    Conclusions: Nocturnal NIV in stable, oxygen dependent, hypercapnic COPD patients may improve survival but this appears to be at the cost of worsening quality of life.

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