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

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.

• Authors: María José López-Jiménez, Juan F Masa, Jaime Corral, Joaquín Terán, Estrella Ordaz, Maria F Troncoso, Nicolás González-Mangado, Mónica González, Soledad Lopez-Martínez, Pilar De Lucas, José M Marín, Sergi Martí, Trinidad Díaz-Cambriles, Josefa Díaz-de-Atauri, Eusebi Chiner, Felipe Aizpuru, Carlos Egea, Auxiliadora Romero, José M Benítez, Jesús Sánchez-Gómez, Rafael Golpe, Ana Santiago-Recuerda, Silvia Gómez, Ferrán Barbe, Mónica Bengoa, Grupo cooperativo
• Journal: Archivos de bronconeumologia (Arch Bronconeumol) Vol. 52 Issue 3 Pg. 158-65 (Mar 2016) ISSN: 1579-2129 [Electronic] Spain
• PMID: 26656679 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 SEPAR. Published by Elsevier Espana. All rights reserved.

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Continuous Positive Airway Pressure
• Humans
• Length of Stay
• Life Style
• Middle Aged
• Noninvasive Ventilation
• Obesity Hypoventilation Syndrome (therapy)
• Polysomnography
• Prospective Studies
• Quality of Life
• Sample Size
• Time Factors