000070710 001__ 70710
000070710 005__ 20200221144340.0
000070710 0247_ $$2doi$$a10.1136/thoraxjnl-2016-208501
000070710 0248_ $$2sideral$$a106054
000070710 037__ $$aART-2016-106054
000070710 041__ $$aeng
000070710 100__ $$aMasa, J.F.
000070710 245__ $$aNon-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea
000070710 260__ $$c2016
000070710 5060_ $$aAccess copy available to the general public$$fUnrestricted
000070710 5203_ $$aBackground 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.
000070710 536__ $$9info:eu-repo/grantAgreement/ES/ISCIII/FIS/PI05-0402
000070710 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc$$uhttp://creativecommons.org/licenses/by-nc/3.0/es/
000070710 590__ $$a8.272$$b2016
000070710 591__ $$aRESPIRATORY SYSTEM$$b4 / 59 = 0.068$$c2016$$dQ1$$eT1
000070710 592__ $$a3.275$$b2016
000070710 593__ $$aPulmonary and Respiratory Medicine$$c2016$$dQ1
000070710 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000070710 700__ $$aCorral, J.
000070710 700__ $$aCaballero, C.
000070710 700__ $$aBarrot, E.
000070710 700__ $$aTeran-Santos, J.
000070710 700__ $$aAlonso-Alvarez, M.L.
000070710 700__ $$aGomez-Garcia, T.
000070710 700__ $$aGonzalez, M.
000070710 700__ $$aLopez-Martin, S.
000070710 700__ $$aDe Lucas, P.
000070710 700__ $$0(orcid)0000-0001-9096-2294$$aMarin, J.M.$$uUniversidad de Zaragoza
000070710 700__ $$aMarti, S.
000070710 700__ $$aDiaz-Cambriles, T.
000070710 700__ $$aChiner, E.
000070710 700__ $$aEgea, C.
000070710 700__ $$aMiranda, E.
000070710 700__ $$aMokhlesi, B.
000070710 700__ $$aGarcia-Ledesma, E.
000070710 700__ $$aSanchez-Quiroga, M.A.
000070710 700__ $$aOrdax, E.
000070710 700__ $$aGonzalez-Mangado, N.
000070710 700__ $$aTroncoso, M.F.
000070710 700__ $$aMartinez-Martinez, M.A.
000070710 700__ $$aCantalejo, O.
000070710 700__ $$aOjeda, E.
000070710 700__ $$aCarrizo, S.J.
000070710 700__ $$aGallego, B.
000070710 700__ $$aPallero, M.
000070710 700__ $$aRamon, M.A.
000070710 700__ $$aDiaz-de-Atauri, J.
000070710 700__ $$aMunoz-Mendez, J.
000070710 700__ $$aSenent, C.
000070710 700__ $$aSancho-Chust, J.N.
000070710 700__ $$aRibas-Solis, F.J.
000070710 700__ $$aRomero, A.
000070710 700__ $$aBenitez, J.M.
000070710 700__ $$aSanchez-Gomez, J.
000070710 700__ $$aGolpe, R.
000070710 700__ $$aSantiago-Recuerda, A.
000070710 700__ $$aGomez, S.
000070710 700__ $$aBengoa, M.
000070710 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000070710 773__ $$g71, 10 (2016), 899-906$$pThorax$$tTHORAX$$x0040-6376
000070710 8564_ $$s399870$$uhttps://zaguan.unizar.es/record/70710/files/texto_completo.pdf$$yVersión publicada
000070710 8564_ $$s52240$$uhttps://zaguan.unizar.es/record/70710/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
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000070710 951__ $$a2020-02-21-13:49:51
000070710 980__ $$aARTICLE