Mid- and Long-Term Efficacy of Non-Invasive Ventilation in Obesity Hypoventilation Syndrome: The Pickwick’s Study.

by | Mar 1, 2016 | CPAP, Human, Obesity, Treatment

López-Jiménez MJ, Masa JF, Corral J, Terán J, Ordaz E, Troncoso MF, González-Mangado N, González M, Lopez-Martínez S, De Lucas P, Marín JM, Martí S, Díaz-Cambriles T, Díaz-de-Atauri J, Chiner E, Aizpuru F, Egea C, Romero A, Benítez JM, Sánchez-Gómez J, Golpe R, Santiago-Recuerda A, Gómez S, Barbe F, Bengoa M; Grupo cooperativo.

Abstract

The Pickwick project was a prospective, randomized and controlled study, which addressed the issue of obesity hypoventilation syndrome (OHS), a growing problem in developed countries. OHS patients were divided according to apnea-hypopnea index (AHI) ≥30 and <30 determined by polysomnography. The group with AHI≥30 was randomized to intervention with lifestyle changes, noninvasive ventilation (NIV) or continuous positive airway pressure (CPAP); the group with AHI<30 received NIV or lifestyle changes. The aim of the study was to evaluate the efficacy of NIV treatment, CPAP and lifestyle changes (control) in the medium and long-term management of patients with OHS. The primary variables were PaCO2 and days of hospitalization, and operating variables were the percentage of dropouts for medical reasons and mortality. Secondary medium-term objectives were: (i)to evaluate clinical-functional effectiveness on quality of life, echocardiographic and polysomnographic variables; (ii)to investigate the importance of apneic events and leptin in the pathogenesis of daytime alveolar hypoventilation and change according to the different treatments; (ii)to investigate whether metabolic, biochemical and vascular endothelial dysfunction disorders depend on the presence of apneas and hypopneasm and (iv)changes in inflammatory markers and endothelial damage according to treatment. Secondary long-term objectives were to evaluate: (i)clinical and functional effectiveness and quality of life with NIV and CPAP; (ii)changes in leptin, inflammatory markers and endothelial damage according to treatment; (iii)changes in pulmonary hypertension and other echocardiographic variables, as well as blood pressure and incidence of cardiovascular events, and (iv)dropout rate and mortality.

Copyright © 2015 SEPAR. Published by Elsevier Espana. All rights reserved.

KEYWORDS: Continuous positive airway pressure; Noninvasive mechanical ventilation; Obesity-hypoventilation syndrome; Presión en la vía aérea positiva continua; Sleep apnea syndrome; Síndrome de apneas de sueño; Síndrome hipoventilación-obesidad; Ventilación mecánica no invasiva

PMID: 26656679