Non-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea.

Autor: Masa JF; San Pedro de Alcántara Hospital, Cáceres, Spain Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain., Corral J; San Pedro de Alcántara Hospital, Cáceres, Spain Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain., Caballero C; Virgen del Rocío Hospital, Sevilla, Spain., Barrot E; Virgen del Rocío Hospital, Sevilla, Spain., Terán-Santos J; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain University Hospital, Burgos, Spain., Alonso-Álvarez ML; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain University Hospital, Burgos, Spain., Gomez-Garcia T; IIS Fundación Jiménez Díaz, Madrid, Spain., González M; Valdecilla Hospital, Santander, Spain., López-Martín S; Gregorio Marañon Hospital, Madrid, Spain., De Lucas P; Gregorio Marañon Hospital, Madrid, Spain., Marin JM; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Miguel Servet Hospital, Zaragoza, Spain., Marti S; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Valld'Hebron Hospital, Barcelona, Spain., Díaz-Cambriles T; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Doce de Octubre Hospital, Madrid, Spain., Chiner E; San Juan Hospital, Alicante, Spain., Egea C; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Sleep Unit and Respiratory Department, Alava University Hospital IRB, Vitoria, Spain., Miranda E; Araba Health Research Unit, Osakidetza, Alava Hospital, Spain., Mokhlesi B; Department of Medicine, Section of Pulmonary and Critical Care, University of Chicago, Chicago, Illinois, USA., García-Ledesma E; San Pedro de Alcántara Hospital, Cáceres, Spain., Sánchez-Quiroga MÁ; Virgen del Puerto Hospital, Plasencia, Spain., Ordax E; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain University Hospital, Burgos, Spain., González-Mangado N; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain IIS Fundación Jiménez Díaz, Madrid, Spain., Troncoso MF; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain IIS Fundación Jiménez Díaz, Madrid, Spain., Martinez-Martinez MÁ; Valdecilla Hospital, Santander, Spain., Cantalejo O; Valdecilla Hospital, Santander, Spain., Ojeda E; Gregorio Marañon Hospital, Madrid, Spain., Carrizo SJ; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Miguel Servet Hospital, Zaragoza, Spain., Gallego B; Miguel Servet Hospital, Zaragoza, Spain., Pallero M; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Valld'Hebron Hospital, Barcelona, Spain., Ramón MA; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Valld'Hebron Hospital, Barcelona, Spain., Díaz-de-Atauri J; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Doce de Octubre Hospital, Madrid, Spain., Muñoz-Méndez J; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Doce de Octubre Hospital, Madrid, Spain., Senent C; San Juan Hospital, Alicante, Spain., Sancho-Chust JN; San Juan Hospital, Alicante, Spain., Ribas-Solís FJ; Sleep Unit and Respiratory Department, Alava University Hospital IRB, Vitoria, Spain., Romero A; Virgen del Rocío Hospital, Sevilla, Spain., Benítez JM; Virgen de la Macarena Hospital, Sevilla, Spain., Sanchez-Gómez J; Virgen de la Macarena Hospital, Sevilla, Spain., Golpe R; Lucus Augusti Universitary Hospital, Lugo, Spain., Santiago-Recuerda A; La Paz Hospital, Madrid, Spain., Gomez S; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Arnau de Vilanova Hospital, Lleida, Spain., Bengoa M; University Hospital, Las Palmas, Spain.
Jazyk: angličtina
Zdroj: Thorax [Thorax] 2016 Oct; Vol. 71 (10), pp. 899-906. Date of Electronic Publication: 2016 Jul 12.
DOI: 10.1136/thoraxjnl-2016-208501
Abstrakt: Background: Non-invasive ventilation (NIV) is an effective form of treatment in patients with obesity hypoventilation syndrome (OHS) who have concomitant severe obstructive sleep apnoea (OSA). However, there is a paucity of evidence on the efficacy of NIV in patients with OHS without severe OSA. We performed a multicentre randomised clinical trial to determine the comparative efficacy of NIV versus lifestyle modification (control group) using daytime arterial carbon dioxide tension (PaCO2) as the main outcome measure.
Methods: Between May 2009 and December 2014 we sequentially screened patients with OHS without severe OSA. Participants were randomised to NIV versus lifestyle modification and were followed for 2 months. Arterial blood gas parameters, clinical symptoms, health-related quality of life assessments, polysomnography, spirometry, 6-min walk distance test, blood pressure measurements and healthcare resource utilisation were evaluated. Statistical analysis was performed using intention-to-treat analysis.
Results: A total of 365 patients were screened of whom 58 were excluded. Severe OSA was present in 221 and the remaining 86 patients without severe OSA were randomised. NIV led to a significantly larger improvement in PaCO2 of -6 (95% CI -7.7 to -4.2) mm Hg versus -2.8 (95% CI -4.3 to -1.3) mm Hg, (p<0.001) and serum bicarbonate of -3.4 (95% CI -4.5 to -2.3) versus -1 (95% CI -1.7 to -0.2 95% CI)  mmol/L (p<0.001). PaCO2 change adjusted for NIV compliance did not further improve the inter-group statistical significance. Sleepiness, some health-related quality of life assessments and polysomnographic parameters improved significantly more with NIV than with lifestyle modification. Additionally, there was a tendency towards lower healthcare resource utilisation in the NIV group.
Conclusions: NIV is more effective than lifestyle modification in improving daytime PaCO2, sleepiness and polysomnographic parameters. Long-term prospective studies are necessary to determine whether NIV reduces healthcare resource utilisation, cardiovascular events and mortality.
Trial Registration Number: NCT01405976; results.
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Databáze: MEDLINE