Non-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea. Issue 10 (12th July 2016)

• Record Type: Journal Article
• Authors: Masa, Juan F; Corral, Jaime; Caballero, Candela; Barrot, Emilia; Terán-Santos, Joaquin; Alonso-Álvarez, Maria L; Gomez-Garcia, Teresa; González, Mónica; López-Martín, Soledad; De Lucas, Pilar; Marin, José M; Marti, Sergi; Díaz-Cambriles, Trinidad; Chiner, Eusebi; Egea, Carlos; Miranda, Erika; Mokhlesi, Babak; García-Ledesma, Estefanía; Sánchez-Quiroga, M-Ángeles; Ordax, Estrella; González-Mangado, Nicolás; Troncoso, Maria F; Martinez-Martinez, Maria-Ángeles; Cantalejo, Olga; Ojeda, Elena; Carrizo, Santiago J; Gallego, Begoña; Pallero, Mercedes; Ramón, M Antonia; Díaz-de-Atauri, Josefa; Muñoz-Méndez, Jesús; Senent, Cristina; Sancho-Chust, Jose N; Ribas-Solís, Francisco J; Romero, Auxiliadora; Benítez, José M; Sanchez-Gómez, Jesús; Golpe, Rafael; Santiago-Recuerda, Ana; Gomez, Silvia; Bengoa, Mónica;
• Is Part Of: Thorax. Volume 71:Issue 10(2016)
• Page Start: 899
• Page End: 906
• Publication Date: 2016-07-12
• Subjects: Sleep apnoea -- Non invasive ventilation; Chest -- Diseases -- Periodicals; Thorax; Chest -- Diseases; Periodicals; Periodicals; 617.54
• DOI: 10.1136/thoraxjnl-2016-208501
• Languages: English
• ISSNs: 0040-6376

Abstract

Abstract : 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.