Trinidad Díaz-Cambriles, Mónica Bengoa, Ferrán Barbe, Silvia Gómez, Ana Santiago-Recuerda, Rafael Golpe, Jesús Sánchez-Gómez, José M Benítez, Auxiliadora Romero, Carlos Egea, Felipe Aizpuru, Eusebi Chiner, Josefa Díaz-de-Atauri, María José López-Jiménez, Sergi Martí, José M Marín, Pilar De Lucas, Soledad Lopez-Martínez, Mónica González, Nicolás González-Mangado, Maria F Troncoso, Estrella Ordaz, Joaquín Terán, Jaime Corral, Juan F Masa
Journal: Archivos de bronconeumologia 2016;52(3):158-65
PMID: 26656679
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.
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