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Title: A randomised controlled trial of CPAP versus non-invasive ventilation for initial treatment of obesity hypoventilation syndrome
Austin Authors: Howard, Mark E ;Piper, Amanda J;Stevens, Bronwyn ;Holland, Anne E ;Yee, Brendon J;Dabscheck, Eli;Mortimer, Duncan;Burge, Angela T ;Flunt, Daniel;Buchan, Catherine;Rautela, Linda ;Sheers, Nicole ;Hillman, David;Berlowitz, David J 
Affiliation: Institute for Breathing and Sleep, Heidelberg, Victoria, Australia
Austin Health, Heidelberg, Victoria, Australia
University of Melbourne, Parkville, Victoria, Australia
Monash University, Clayton, Victoria, Australia
Royal Prince Alfred Hospital, Camperdown, NSW, Australia
Alfred Health, Melbourne, Victoria, Australia
La Trobe University, Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Issue Date: May-2017
Date: 2016-11-15
Publication information: Thorax 2017; 72(5): 437-444
Abstract: BACKGROUND: Obesity hypoventilation syndrome (OHS) is the most common indication for home ventilation, although the optimal therapy remains unclear, particularly for severe disease. We compared Bi-level and continuous positive airways pressure (Bi-level positive airway pressure (PAP); CPAP) for treatment of severe OHS. METHODS: We conducted a multicentre, parallel, double-blind trial for initial treatment of OHS, with participants randomised to nocturnal Bi-level PAP or CPAP for 3 months. The primary outcome was frequency of treatment failure (hospital admission, persistent ventilatory failure or non-adherence); secondary outcomes included health-related quality of life (HRQoL) and sleepiness. RESULTS: Sixty participants were randomised; 57 completed follow-up and were included in analysis (mean age 53 years, body mass index 55 kg/m2, PaCO2 60 mm Hg). There was no difference in treatment failure between groups (Bi-level PAP, 14.8% vs CPAP, 13.3%, p=0.87). Treatment adherence and wake PaCO2 were similar after 3 months (5.3 hours/night Bi-level PAP, 5.0 hours/night CPAP, p=0.62; PaCO2 44.2 and 45.9 mm Hg, respectively, p=0.60). Between-group differences in improvement in sleepiness (Epworth Sleepiness Scale 0.3 (95% CI -2.8, 3.4), p=0.86) and HRQoL (Short Form (SF)36-SF6d 0.025 (95% CI -0.039, 0.088), p=0.45) were not significant. Baseline severity of ventilatory failure (PaCO2) was the only significant predictor of persistent ventilatory failure at 3 months (OR 2.3, p=0.03). CONCLUSIONS: In newly diagnosed severe OHS, Bi-level PAP and CPAP resulted in similar improvements in ventilatory failure, HRQoL and adherence. Baseline PaCO2 predicted persistent ventilatory failure on treatment. Long-term studies are required to determine whether these treatments have different cost-effectiveness or impact on mortality. TRIAL REGISTRATION NUMBER: ACTRN12611000874910, results.
DOI: 10.1136/thoraxjnl-2016-208559
ORCID: 0000-0003-2543-8722
Journal: Thorax
PubMed URL:
Type: Journal Article
Subjects: Non invasive ventilation
Sleep apnoea
Type of Clinical Study or Trial: Randomized Controlled Clinical Trial/Controlled Clinical Trial
Appears in Collections:Journal articles

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