title: 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.affiliation: Servicio de Neumología, Hospital San Pedro de Alcántara, Cáceres, España.
authors.forename: María José
authors.initials: MJ
authors.lastname: López-Jiménez
authors.affiliation: Servicio de Neumología, Hospital San Pedro de Alcántara, Cáceres, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España. Electronic address: fmasa@separ.es.
authors.forename: Juan F
authors.initials: JF
authors.lastname: Masa
authors.affiliation: Servicio de Neumología, Hospital San Pedro de Alcántara, Cáceres, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: Jaime
authors.initials: J
authors.lastname: Corral
authors.affiliation: Unidad del Sueño, Complejo Asistencial de Burgos, Burgos, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: Joaquín
authors.initials: J
authors.lastname: Terán
authors.affiliation: Unidad del Sueño, Complejo Asistencial de Burgos, Burgos, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: Estrella
authors.initials: E
authors.lastname: Ordaz
authors.affiliation: Sección de Neumología, IIS Fundación Jiménez Díaz, Madrid, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: Maria F
authors.initials: MF
authors.lastname: Troncoso
authors.affiliation: Sección de Neumología, IIS Fundación Jiménez Díaz, Madrid, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: Nicolás
authors.initials: N
authors.lastname: González-Mangado
authors.affiliation: Unidad de Sueño y Ventilación, Servicio de Neumología, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, España.
authors.forename: Mónica
authors.initials: M
authors.lastname: González
authors.affiliation: Servicio de Neumología, Hospital Gregorio Marañón, Madrid, España.
authors.forename: Soledad
authors.initials: S
authors.lastname: Lopez-Martínez
authors.affiliation: Servicio de Neumología, Hospital Gregorio Marañón, Madrid, España.
authors.forename: Pilar
authors.initials: P
authors.lastname: De Lucas
authors.affiliation: Servicio de Neumología, Hospital Miguel Servet, Zaragoza, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: José M
authors.initials: JM
authors.lastname: Marín
authors.affiliation: Servicio de Neumología, Hospital Vall d'Hebron, Barcelona, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: Sergi
authors.initials: S
authors.lastname: Martí
authors.affiliation: Servicio de Neumología, Hospital Doce de Octubre, Madrid, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: Trinidad
authors.initials: T
authors.lastname: Díaz-Cambriles
authors.affiliation: Servicio de Neumología, Hospital Doce de Octubre, Madrid, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: Josefa
authors.initials: J
authors.lastname: Díaz-de-Atauri
authors.affiliation: Servicio de Neumología, Hospital San Juan, Alicante, España.
authors.forename: Eusebi
authors.initials: E
authors.lastname: Chiner
authors.affiliation: Unidad de Investigación de Araba, Departamento de Estadística, Hospital Álava, Vitoria-Gasteiz, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: Felipe
authors.initials: F
authors.lastname: Aizpuru
authors.affiliation: Unidad de Sueño, Departamento de Neumología, Hospital Universitario de Álava IRB, Vitoria-Gasteiz, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: Carlos
authors.initials: C
authors.lastname: Egea
authors.affiliation: Unidad de Sueño de la Unidad Médico-Quirúrgica de Enfermedades respiratorias, Hospital Virgen del Rocío, Sevilla, España.
authors.forename: Auxiliadora
authors.initials: A
authors.lastname: Romero
authors.affiliation: Servicio de Neumología, Hospital Universitario Virgen Macarena, Sevilla, España.
authors.forename: José M
authors.initials: JM
authors.lastname: Benítez
authors.affiliation: Servicio de Neumología, Hospital Universitario Virgen Macarena, Sevilla, España.
authors.forename: Jesús
authors.initials: J
authors.lastname: Sánchez-Gómez
authors.affiliation: Servicio de Neumología, Hospital Universitario Lucus Augusti, Lugo, España.
authors.forename: Rafael
authors.initials: R
authors.lastname: Golpe
authors.affiliation: Servicio de Neumología, Hospital La Paz, Madrid, España.
authors.forename: Ana
authors.initials: A
authors.lastname: Santiago-Recuerda
authors.affiliation: Servicio de Neumología, Hospital Arnau de Vilanova, Lleida, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: Silvia
authors.initials: S
authors.lastname: Gómez
authors.affiliation: Servicio de Neumología, Hospital Arnau de Vilanova, Lleida, España; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, España.
authors.forename: Ferrán
authors.initials: F
authors.lastname: Barbe
authors.affiliation: Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, España.
authors.forename: Mónica
authors.initials: M
authors.lastname: Bengoa
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D045422:Continuous Positive Airway Pressure; D006801:Humans; D007902:Length of Stay; D008019:Life Style; D008875:Middle Aged; D063087:Noninvasive Ventilation; D010845:Obesity Hypoventilation Syndrome / Q000628:therapy*; D017286:Polysomnography; D011446:Prospective Studies; D011788:Quality of Life; D018401:Sample Size; D013997:Time Factors
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