CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial

R D McEvoy¹, R J Pierce², D Hillman³, A Esterman⁴, E E Ellis⁵, P G Catcheside¹, F J O’Donoghue^1,2, D J Barnes⁶, R R Grunstein⁶ on behalf of the Australian trial of non-invasive Ventilation in Chronic Airflow Limitation (AVCAL) Study Group

¹ Adelaide Institute for Sleep Health, Repatriation General Hospital and Flinders University, Australia
² Institute for Breathing and Sleep, Austin Hospital, Heidelberg, Victoria, Australia
³ WA Sleep Disorders Research Institute, Queen Elizabeth II Medical Centre, Nedlands, Western Australia
⁴ School of Nursing and Midwifery, University of South Australia, Adelaide, Australia
⁵ School of Physiotherapy, Faculty of Health Sciences, University of Sydney, Sydney, Australia
⁶ Sleep Research Group, Woolcock Institute, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia

Professor D McEvoy, Adelaide Institute for Sleep Health, Repatriation General Hospital, Daw Park, South Australia, Australia 5000; doug.mcevoy{at}health.sa.gov.au

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). A study was undertaken to determine the effects of nocturnal non-invasive bi-level pressure support ventilation (NIV) on survival, lung function and quality of life in patients with severe hypercapnic COPD.

Method: A multicentre, open-label, randomised controlled trial of NIV plus long-term oxygen therapy (LTOT) versus LTOT alone was performed in four Australian University Hospital sleep/respiratory medicine departments in patients with severe stable smoking-related COPD (forced expiratory volume in 1 s (FEV_1.0) <1.5 litres or <50% predicted and ratio of FEV_1.0 to forced vital capacity (FVC) <60% with awake arterial carbon dioxide tension (PaCO₂) >46 mm Hg and on LTOT for at least 3 months) and age <80 years. Patients with sleep apnoea (apnoea-hypopnoea index >20/h) or morbid obesity (body mass index >40) were excluded. Outcome measures were survival, spirometry, arterial blood gases, polysomnography, general and disease-specific quality of life and mood.

Results: 144 patients were randomised (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 (SD) nightly use 4.5 (3.2) h). Compared with LTOT alone, NIV (mean follow-up 2.21 years, range 0.01–5.59) showed an improvement in survival with the adjusted but not the unadjusted Cox model (adjusted hazard ratio (HR) 0.63, 95% CI 0.40 to 0.99, p = 0.045; unadjusted HR 0.82, 95% CI 0.53 to 1.25, p = NS). FEV_1.0 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 vigour.

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

Trial registration number: ACTRN12605000205639

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