Multicentre randomised placebo-controlled trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease

aval University (Canada)0 个研究点目标入组 600 人开始时间: 2007年12月21日最近更新: 2015年1月13日

适应症

试验速览

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•1. Patients with a diagnosis of COPD supported by an history of past or current smoking and obstructive disease with forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) less than 60%
•2. Presence of mild-to-moderate daytime hypoxemia with a daytime partial pressure of oxygen in arterial blood (paO2) in the range of 56 - 69 mmHg
•3. Patients fulfilling our definition of nocturnal oxygen desaturation: greater than or equal to 30% of the recording time with transcutaneous arterial oxygen saturation less than 90% on two consecutive recordings

•1. Patients fulfilling the usual criteria for continuous oxygen therapy (CONT-O2) at study entry:
•1.1. PaO2 less than or equal to 55 mmHg, or
•1.2. PaO2 less than or equal to 59 mmHg with clinical evidence of at least one of the following:
•1.2.1. Pulmonary hypertension
•1.2.2. Right ventricular hypertrophy
•1.2.3. Cor pulmonale
•1.2.4. Haematocrit greater than or equal to 55%
•2. Patients with sleep apnea (defined by an apnoea/hypopnoea index of greater than or equal to 15 events/hour
•3. Patients currently on nocturnal oxygen therapy (N-O2)
•4. Patients with known left heart or congenital heart diseases, interstitial lung diseases, bronchiectasis as the main cause of their obstructive disease, lung carcinoma or other severe diseases that could influence survival (hepatic cirrhosis and chronic renal failure)

发起方

aval University (Canada)