Medline ® Abstract for Reference 23
of 'Nocturnal ventilatory support in COPD'
Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial.
McEvoy RD, Pierce RJ, Hillman D, Esterman A, Ellis EE, Catcheside PG, O'Donoghue FJ, Barnes DJ, Grunstein RR, Australian trial of non-invasive Ventilation in Chronic Airflow Limitation (AVCAL) Study Group
Thorax. 2009;64(7):561. Epub 2009 Feb 12.
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 (FEV1.0)<1.5 litres or<50% predicted and ratio of FEV1.0 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). 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 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.
Adelaide Institute for Sleep Health, Repatriation General Hospital and Flinders University, Australia. firstname.lastname@example.org