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Clinical InvestigationsCOPDLong-term Controlled Trial of Nocturnal Nasal Positive Pressure Ventilation in Patients With Severe COPD
Section snippets
Patient Selection
Eighty patients with severe COPD from the pulmonary clinics oftwo hospitals in the Canary Islands (Hospital Clinico and Hospital Nuestra Señora de La Candelaria, Canary Islands, Spain) wereasked to participate in the study, which was approved by the humansstudy committee at both institutions. All patients signed the informedconsent and were enrolled between 1995 and 1997. The patients wereincluded if they met the following criteria: age from 45 to 75 years, smoking history of > 20 pack-years,
Patient Characteristics
The 52 patients were randomized into one group treated with NPPV(n = 26) and a control group (n = 26). In spite of theencouragement, five patients from the treatment group did not tolerateventilation within the first 3 weeks. All complained about pressuresbeing too high. Another patient stopped participation after asignificant aortic stenosis was diagnosed at a follow-upechocardiography. Two patients from the control group also abandonedthe trial because of abnormal echocardiographic findings
Discussion
To our knowledge, this prospective study is thelargest and longest prospective, randomized, controlled trial of NPPVin patients with stable severe COPD.1011121314313233 Inaddition, it is the only one that analyzes the influence of NPPV on1-year morbidity and mortality. Over this time, we were unable todemonstrate an important benefit of NPPV when added to standardtreatment. There was an improvement in the Borg dyspnea scale and inone neuropsychological test at 6 months, but the clinical
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Supported in part by a grant from the Spanish Respiratory Society.