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Non-invasive ventilation
Original article
Non-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea
  1. Juan F Masa1,2,
  2. Jaime Corral1,2,
  3. Candela Caballero3,
  4. Emilia Barrot3,
  5. Joaquin Terán-Santos2,4,
  6. Maria L Alonso-Álvarez2,4,
  7. Teresa Gomez-Garcia5,
  8. Mónica González6,
  9. Soledad López-Martín7,
  10. Pilar De Lucas7,
  11. José M Marin2,8,
  12. Sergi Marti2,9,
  13. Trinidad Díaz-Cambriles2,10,
  14. Eusebi Chiner11,
  15. Carlos Egea2,12,
  16. Erika Miranda13,
  17. Babak Mokhlesi14,
  18. on behalf of the Spanish Sleep Network,
  19. Estefanía García-Ledesma1,
  20. M-Ángeles Sánchez-Quiroga15,
  21. Estrella Ordax2,4,
  22. Nicolás González-Mangado2,5,
  23. Maria F Troncoso2,5,
  24. Maria-Ángeles Martinez-Martinez6,
  25. Olga Cantalejo6,
  26. Elena Ojeda7,
  27. Santiago J Carrizo2,8,
  28. Begoña Gallego8,
  29. Mercedes Pallero2,9,
  30. M Antonia Ramón2,9,
  31. Josefa Díaz-de-Atauri2,10,
  32. Jesús Muñoz-Méndez2,10,
  33. Cristina Senent11,
  34. Jose N Sancho-Chust11,
  35. Francisco J Ribas-Solís12,
  36. Auxiliadora Romero3,
  37. José M Benítez16,
  38. Jesús Sanchez-Gómez16,
  39. Rafael Golpe17,
  40. Ana Santiago-Recuerda18,
  41. Silvia Gomez2,19,
  42. Mónica Bengoa20
  1. 1San Pedro de Alcántara Hospital, Cáceres, Spain
  2. 2Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain
  3. 3Virgen del Rocío Hospital, Sevilla, Spain
  4. 4University Hospital, Burgos, Spain
  5. 5IIS Fundación Jiménez Díaz, Madrid, Spain
  6. 6Valdecilla Hospital, Santander, Spain
  7. 7Gregorio Marañon Hospital, Madrid, Spain
  8. 8Miguel Servet Hospital, Zaragoza, Spain
  9. 9Valld'Hebron Hospital, Barcelona, Spain
  10. 10Doce de Octubre Hospital, Madrid, Spain
  11. 11San Juan Hospital, Alicante, Spain
  12. 12Sleep Unit and Respiratory Department, Alava University Hospital IRB, Vitoria, Spain
  13. 13Araba Health Research Unit, Osakidetza, Alava Hospital, Spain
  14. 14Department of Medicine, Section of Pulmonary and Critical Care, University of Chicago, Chicago, Illinois, USA
  15. 15Virgen del Puerto Hospital, Plasencia, Spain
  16. 16Virgen de la Macarena Hospital, Sevilla, Spain
  17. 17Lucus Augusti Universitary Hospital, Lugo, Spain
  18. 18La Paz Hospital, Madrid, Spain
  19. 19Arnau de Vilanova Hospital, Lleida, Spain
  20. 20University Hospital, Las Palmas, Spain
  1. Correspondence to Dr Juan F Masa, C/Rafael Alberti 12, Cáceres 10005, Spain; fmasa{at}separ.es

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.

  • Sleep apnoea
  • Non invasive ventilation

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/thoraxjnl-2016-208501

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