Juan F Masa1, Babak Mokhlesi2, Iván Benítez3, Francisco Javier Gomez de Terreros4, Maria Ángeles Sánchez-Quiroga5, Auxiliadora Romero6, Candela Caballero-Eraso6, Joaquin Terán-Santos7, Maria Luz Alonso-Álvarez7, Maria F Troncoso8, Mónica González9, Soledad López-Martín10, José M Marin11, Sergi Martí12, Trinidad Díaz-Cambriles13, Eusebi Chiner14, Carlos Egea15, Javier Barca16, Francisco-José Vázquez-Polo17, Miguel A Negrín17, María Martel-Escobar17, Ferran Barbe3, Jaime Corral4. 1. Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Cáceres, Spain. Electronic address: fmasa@separ.es. 2. Department of Medicine, University of Chicago, Chicago, IL, USA. 3. Respiratory Department, Institut de Recerca Biomédica de LLeida (IRBLLEIDA), Lleida, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain. 4. Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Cáceres, Spain. 5. Respiratory Department, Virgen del Puerto Hospital, Plasencia, Cáceres, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Cáceres, Spain. 6. CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Sevilla, Spain. 7. CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, University Hospital, Burgos, Spain. 8. CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, IIS Fundación Jiménez Díaz, Madrid, Spain. 9. Respiratory Department, Valdecilla Hospital, Santander, Spain. 10. Respiratory Department, Gregorio Marañon Hospital, Madrid, Spain. 11. CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Miguel Servet Hospital, Zaragoza, Spain. 12. CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Valld'Hebron Hospital, Barcelona, Spain. 13. CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Doce de Octubre Hospital, Madrid, Spain. 14. Respiratory Department, San Juan Hospital, Alicante, Spain. 15. CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Alava University Hospital IRB, Vitoria, Spain. 16. Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Cáceres, Spain; Nursing Department, Extremadura University, Cáceres, Spain. 17. Department of Quantitative Methods, Las Palmas de Gran Canarias University Canary Islands, Spain.
Abstract
BACKGROUND:Obesity hypoventilation syndrome is commonly treated with continuous positive airway pressure or non-invasive ventilation during sleep. Non-invasive ventilation is more complex and costly than continuous positive airway pressure but might be advantageous because it provides ventilatory support. To date there have been no long-term trials comparing these treatment modalities. We therefore aimed to determine the long-term comparative effectiveness of both treatment modalities. METHODS: We did a multicentre, open-label, randomised controlled trial at 16 clinical sites in Spain. We included patients aged 15-80 years with untreated obesity hypoventilation syndrome and an apnoea-hypopnoea index of 30 or more events per h. We randomly assigned patients, using simple randomisation through an electronic database, to receive treatment with either non-invasive ventilation or continuous positive airway pressure. Both investigators and patients were aware of the treatment allocation. The research team was not involved in deciding hospital treatment, duration of treatment in the hospital, and adjustment of medications, as well as adjudicating cardiovascular events or cause of mortality. Treating clinicians from the routine care team were not aware of the treatment allocation. The primary outcome was the number of hospitalisation days per year. The analysis was done according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT01405976. FINDINGS:From May 4, 2009, to March 25, 2013, 100 patients were randomly assigned to the non-invasive ventilation group and 115 to the continuous positive airway pressure group, of which 97 patients in the non-invasive ventilation group and 107 in the continuous positive airway pressure group were included in the analysis. The median follow-up was 5·44 years (IQR 4·45-6·37) for all patients, 5·37 years (4·36-6·32) in the continuous positive airway pressure group, and 5·55 years (4·53-6·50) in the non-invasive ventilation group. The mean hospitalisation days per patient-year were 1·63 (SD 3·74) in the continuous positive airway pressure group and 1·44 (3·07) in the non-invasive ventilation group (adjusted rate ratio 0·78, 95% CI 0·34-1·77; p=0·561). Adverse events were similar between both groups. INTERPRETATION: In stable patients with obesity hypoventilation syndrome and severe obstructive sleep apnoea, non-invasive ventilation and continuous positive airway pressure have similar long-term effectiveness. Given that continuous positive airway pressure has lower complexity and cost, continuous positive airway pressure might be the preferred first-line positive airway pressure treatment modality until more studies become available. FUNDING: Instituto de Salud Carlos III, Spanish Respiratory Foundation, and Air Liquide Spain.
RCT Entities:
BACKGROUND:Obesity hypoventilation syndrome is commonly treated with continuous positive airway pressure or non-invasive ventilation during sleep. Non-invasive ventilation is more complex and costly than continuous positive airway pressure but might be advantageous because it provides ventilatory support. To date there have been no long-term trials comparing these treatment modalities. We therefore aimed to determine the long-term comparative effectiveness of both treatment modalities. METHODS: We did a multicentre, open-label, randomised controlled trial at 16 clinical sites in Spain. We included patients aged 15-80 years with untreated obesity hypoventilation syndrome and an apnoea-hypopnoea index of 30 or more events per h. We randomly assigned patients, using simple randomisation through an electronic database, to receive treatment with either non-invasive ventilation or continuous positive airway pressure. Both investigators and patients were aware of the treatment allocation. The research team was not involved in deciding hospital treatment, duration of treatment in the hospital, and adjustment of medications, as well as adjudicating cardiovascular events or cause of mortality. Treating clinicians from the routine care team were not aware of the treatment allocation. The primary outcome was the number of hospitalisation days per year. The analysis was done according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT01405976. FINDINGS: From May 4, 2009, to March 25, 2013, 100 patients were randomly assigned to the non-invasive ventilation group and 115 to the continuous positive airway pressure group, of which 97 patients in the non-invasive ventilation group and 107 in the continuous positive airway pressure group were included in the analysis. The median follow-up was 5·44 years (IQR 4·45-6·37) for all patients, 5·37 years (4·36-6·32) in the continuous positive airway pressure group, and 5·55 years (4·53-6·50) in the non-invasive ventilation group. The mean hospitalisation days per patient-year were 1·63 (SD 3·74) in the continuous positive airway pressure group and 1·44 (3·07) in the non-invasive ventilation group (adjusted rate ratio 0·78, 95% CI 0·34-1·77; p=0·561). Adverse events were similar between both groups. INTERPRETATION: In stable patients with obesity hypoventilation syndrome and severe obstructive sleep apnoea, non-invasive ventilation and continuous positive airway pressure have similar long-term effectiveness. Given that continuous positive airway pressure has lower complexity and cost, continuous positive airway pressure might be the preferred first-line positive airway pressure treatment modality until more studies become available. FUNDING: Instituto de Salud Carlos III, Spanish Respiratory Foundation, and Air Liquide Spain.
Authors: Michael V Braganza; Patrick J Hanly; Kristin L Fraser; Willis H Tsai; Sachin R Pendharkar Journal: J Clin Sleep Med Date: 2020-09-15 Impact factor: 4.062
Authors: Juan F Masa; Iván D Benítez; Shahrokh Javaheri; Maria Victoria Mogollon; Maria Á Sánchez-Quiroga; Francisco J Gomez de Terreros; Jaime Corral; Rocio Gallego; Auxiliadora Romero; Candela Caballero-Eraso; Estrella Ordax-Carbajo; María F Troncoso; Mónica González; Soledad López-Martín; José M Marin; Sergi Martí; Trinidad Díaz-Cambriles; Eusebi Chiner; Carlos Egea; Javier Barca; Ferrán Barbé; Babak Mokhlesi Journal: J Clin Sleep Med Date: 2022-04-01 Impact factor: 4.062