A randomised controlled trial and cost-effectiveness analysis of high-frequency oscillatory ventilation against conventional artificial ventilation for adults with acute respiratory distress syndrome. The OSCAR (OSCillation in ARDS) study

Oxford University (UK)0 个研究点目标入组 1,006 人开始时间: 2007年6月13日最近更新: 2019年5月27日

适应症

试验速览

•1. Age 16 years and over
•2. Weight 35 kg and over
•3. Endotracheal intubation or tracheostomy
•4. Hypoxaemia defined as an arterial oxygen tension/inspired oxygen ratio (PaO2/FiO2) ratio =26.7kPa (200 mmHg), with a Positive End Expiratory Pressure (PEEP) = 5 cmH20, determined on two arterial blood samples 12 hours apart
•5. Bilateral infiltrates on chest radiograph
•6. One or more risk factors for ARDS (including pneumonia, aspiration of gastric contents, inhalation injury, sepsis, major trauma, multiple transfusions, drug overdose, burn injury, acute pancreatitis, or shock)
•7. Predicted to require at least 48 hours of artificial ventilation from the time of randomisation

•1. Patients who could not benefit from HFOV
•1.1. Patients with left atrial hypertension from any cause, diagnosed clinically or with echocardiography or pulmonary artery catheterisation
•1.2. Patients who have been mechanically ventilated for more than 7 days at the point of enrollment
•2. Patients in whom HFOV might be hazardous
•2.1. Patients with airway disease expected to cause expiratory airflow limitation
•2.2. Patients who have had a lung biopsy or resection during this hospital admission
•3. Administrative, practical and ethical exclusions
•3.1. Patients previously enrolled in the OSCAR trial during the same hospital admission
•3.2.Patients refusing consent or patients in whom relatives refuse assent
•3.3. Patients who were ?legally incompetent? prior to their hospital admission
•3.4. Patients whose relatives do not understand written or verbal information for whom an interpreter is not available
•3.5. Patients enrolled in another therapeutic trial in the 30 days prior to randomisation
•3.6. Patients in whom active treatment has been withdrawn or withdrawal is planned

发起方

Oxford University (UK)