A randomised controlled trial of CPAP versus non-invasive ventilation for initial treatment of obesity hypoventilation syndrome

Mark E Howard, Amanda J. Piper, Bronwyn Stevens, Anne E. Holland, Brendon J. Yee, Eli Dabscheck, Duncan Mortimer, Angela T. Burge, Daniel Flunt, Catherine Buchan, Linda Rautela, Nicole Sheers, David Hillman, David J. Berlowitz

Research output: Contribution to journalArticleResearchpeer-review

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 costeffectiveness or impact on mortality. Trial registration number ACTRN12611000874910, results.

Original languageEnglish
Pages (from-to)437-444
Number of pages8
JournalThorax
Volume72
Issue number5
DOIs
Publication statusPublished - 2017

Cite this

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. / A randomised controlled trial of CPAP versus non-invasive ventilation for initial treatment of obesity hypoventilation syndrome. In: Thorax. 2017 ; Vol. 72, No. 5. pp. 437-444.
@article{8257824d3e9d484e88c82208990a8695,
title = "A randomised controlled trial of CPAP versus non-invasive ventilation for initial treatment of obesity hypoventilation syndrome",
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 costeffectiveness or impact on mortality. Trial registration number ACTRN12611000874910, results.",
author = "Howard, {Mark E} and Piper, {Amanda J.} and Bronwyn Stevens and Holland, {Anne E.} and Yee, {Brendon J.} and Eli Dabscheck and Duncan Mortimer and Burge, {Angela T.} and Daniel Flunt and Catherine Buchan and Linda Rautela and Nicole Sheers and David Hillman and Berlowitz, {David J.}",
year = "2017",
doi = "10.1136/thoraxjnl-2016-208559",
language = "English",
volume = "72",
pages = "437--444",
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Howard, ME, Piper, AJ, Stevens, B, Holland, AE, Yee, BJ, Dabscheck, E, Mortimer, D, Burge, AT, Flunt, D, Buchan, C, Rautela, L, Sheers, N, Hillman, D & Berlowitz, DJ 2017, 'A randomised controlled trial of CPAP versus non-invasive ventilation for initial treatment of obesity hypoventilation syndrome' Thorax, vol. 72, no. 5, pp. 437-444. https://doi.org/10.1136/thoraxjnl-2016-208559

A randomised controlled trial of CPAP versus non-invasive ventilation for initial treatment of obesity hypoventilation syndrome. / 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.

In: Thorax, Vol. 72, No. 5, 2017, p. 437-444.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - A randomised controlled trial of CPAP versus non-invasive ventilation for initial treatment of obesity hypoventilation syndrome

AU - Howard, Mark E

AU - Piper, Amanda J.

AU - Stevens, Bronwyn

AU - Holland, Anne E.

AU - Yee, Brendon J.

AU - Dabscheck, Eli

AU - Mortimer, Duncan

AU - Burge, Angela T.

AU - Flunt, Daniel

AU - Buchan, Catherine

AU - Rautela, Linda

AU - Sheers, Nicole

AU - Hillman, David

AU - Berlowitz, David J.

PY - 2017

Y1 - 2017

N2 - 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 costeffectiveness or impact on mortality. Trial registration number ACTRN12611000874910, results.

AB - 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 costeffectiveness or impact on mortality. Trial registration number ACTRN12611000874910, results.

UR - http://www.scopus.com/inward/record.url?scp=85019558511&partnerID=8YFLogxK

U2 - 10.1136/thoraxjnl-2016-208559

DO - 10.1136/thoraxjnl-2016-208559

M3 - Article

VL - 72

SP - 437

EP - 444

JO - Thorax

JF - Thorax

SN - 0040-6376

IS - 5

ER -