Effects on surgical site infection of an individualized perioperative openlung ventilatory strategy with high versus conventional inspiratory oxygen fraction (iPROVEO2). A comparative, prospective, multicenter, randomized controlled trial. - iPROVE-O2

Francisco Javier Belda Nacher0 个研究点目标入组 756 人开始时间: 2016年11月17日最近更新: 2019年12月10日

试验速览

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•1) Male or female patients =18 years old,
•2) Body mass index (BMI) of <35 kg/m2
•3) Scheduled for major abdominal (laparotomy and laparoscopic) surgery with an expected surgery duration of more than 2h.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 456
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 300

•1) < 18 years
•2) Pregnant woman or in breast-feeding status
•3) Body mass index (BMI) > 35 Kg/m2
•4) Moderate or severe acute respiratory distress syndrome (ARDS; PaO2/ FIO2 < 200 mmHg)
•5) Diagnosis of heart failure defined as a cardiac index < 2.5 ml/min/m2 or > 2.5 when = 5µg/kg/min dobutamine is required, or suspected heart failure according to clinical signs (hypotension, oliguria, pulmonary edema) together with NT-proBNP > 13pg/ml,
•6) Suspected intracranial hypertension (> 15 mmHg)
•7) Presence of pneumothorax or giant bullae on a chest radiograph or computed tomography (CT)
•8) Patients participating in another interventional study.

发起方

Francisco Javier Belda Nacher