Juan F Masa1,2, Jaime Corral1,2, Auxiliadora Romero3, Candela Caballero3, Joaquin Terán-Santos4,2, Maria L Alonso-Álvarez4,2, Teresa Gomez-Garcia5, Mónica González6, Soledad López-Martínez7, Pilar De Lucas7, José M Marin8,2, Sergi Marti9,2, Trinidad Díaz-Cambriles10,2, Eusebi Chiner11, Miguel Merchan1, Carlos Egea12,2, Ana Obeso13, Babak Mokhlesi14. 1. San Pedro de Alcántara Hospital, Cáceres, Spain. 2. CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain. 3. Virgen del Rocío Hospital, Sevilla, Spain. 4. University Hospital, Burgos, Spain. 5. IIS Fundación Jiménez Díaz, Madrid, Spain. 6. Valdecilla Hospital, Santander, Spain. 7. Gregorio Marañon Hospital, Madrid, Spain. 8. Miguel Servet Hospital, Zaragoza, Spain. 9. Valld'Hebron Hospital, Barcelona, Spain. 10. Doce de Octubre Hospital, Madrid, Spain. 11. San Juan Hospital, Alicante, Spain. 12. Sleep Unit, Respiratory Department, Alava University Hospital IRB, Vitoria, Spain. 13. Department of Physiology, University of Valladolid, Spain. 14. Department of Medicine, Section of Pulmonary and Critical Care, University of Chicago, Chicago, IL.
Abstract
STUDY OBJECTIVES:Low flow supplemental oxygen is commonly prescribed to patients with obesity hypoventilation syndrome (OHS). However, there is a paucity of data regarding its efficacy and safety. The objective of this study was to assess the medium-term treatment efficacy of adding supplemental oxygen therapy to commonly prescribed treatment modalities in OHS. METHODS: In this post hoc analysis of a previous randomized controlled trial, we studied 302 sequentially screened OHS patients who were randomly assigned to noninvasive ventilation, continuous positive airway pressure, or lifestyle modification. Outcomes at 2 mo included arterial blood gases, symptoms, quality of life, blood pressure, polysomnography, spirometry, 6-min walk distance, and hospital resource utilization. Statistical analysis comparing patients with and without oxygen therapy in the three treatment groups was performed using an intention-to-treat analysis. RESULTS: In the noninvasive ventilation group, supplemental oxygen reduced systolic blood pressure although this could be also explained by a reduction in body weight experienced in this group. In the continuous positive airway pressure group, supplemental oxygen increased the frequency of morning confusion. In the lifestyle modification group, supplemental oxygen increased compensatory metabolic alkalosis and decreased the apnea-hypopnea index during sleep. Oxygen therapy was not associated with an increase in hospital resource utilization in any of the groups. CONCLUSIONS: After 2 mo of follow-up, chronic oxygen therapy produced marginal changes that were insufficient to consider it, globally, as beneficial or deleterious. Because supplemental oxygen therapy did not increase hospital resource utilization, we recommend prescribing oxygen therapy to patients with OHS who meet criteria with close monitoring. Long-term studies examining outcomes such as incident cardiovascular morbidity and mortality are necessary. CLINICAL TRIALS REGISTRATION: Clinicaltrial.gov, ID: NCT01405976.
RCT Entities:
STUDY OBJECTIVES: Low flow supplemental oxygen is commonly prescribed to patients with obesity hypoventilation syndrome (OHS). However, there is a paucity of data regarding its efficacy and safety. The objective of this study was to assess the medium-term treatment efficacy of adding supplemental oxygen therapy to commonly prescribed treatment modalities in OHS. METHODS: In this post hoc analysis of a previous randomized controlled trial, we studied 302 sequentially screened OHSpatients who were randomly assigned to noninvasive ventilation, continuous positive airway pressure, or lifestyle modification. Outcomes at 2 mo included arterial blood gases, symptoms, quality of life, blood pressure, polysomnography, spirometry, 6-min walk distance, and hospital resource utilization. Statistical analysis comparing patients with and without oxygen therapy in the three treatment groups was performed using an intention-to-treat analysis. RESULTS: In the noninvasive ventilation group, supplemental oxygen reduced systolic blood pressure although this could be also explained by a reduction in body weight experienced in this group. In the continuous positive airway pressure group, supplemental oxygen increased the frequency of morning confusion. In the lifestyle modification group, supplemental oxygen increased compensatory metabolic alkalosis and decreased the apnea-hypopnea index during sleep. Oxygen therapy was not associated with an increase in hospital resource utilization in any of the groups. CONCLUSIONS: After 2 mo of follow-up, chronic oxygen therapy produced marginal changes that were insufficient to consider it, globally, as beneficial or deleterious. Because supplemental oxygen therapy did not increase hospital resource utilization, we recommend prescribing oxygen therapy to patients with OHS who meet criteria with close monitoring. Long-term studies examining outcomes such as incident cardiovascular morbidity and mortality are necessary. CLINICAL TRIALS REGISTRATION: Clinicaltrial.gov, ID: NCT01405976.
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