The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 12
- 主要终点
- adherence to our explicit mechanical ventilation protocols;
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is a common and catastrophic complication of critical illness related to burns, motor vehicle accidents, or overwhelming infection. ARDS kills 40-70% of affected patients. Patients with ARDS require life support in the form of a ventilator to breathe for them while their lungs heal. Ironically, ventilators can cause further damage to the lungs. We are conducting a study comparing 2 methods to protect the lungs from further damage. One method uses standard mechanical ventilators and the other uses a new type of ventilator, called a high frequency oscillator. We propose to test whether this high frequency oscillation will reduce the relative risk of dying from ARDS. 72 patients from 12 intensive care units in Canada and Saudi Arabia will participate in this preliminary study to test the feasibility of our study methods. If feasible, we plan to move on and conduct a large multinational study to definitively answer this question.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex, 16 years and above;
- •Acute onset of respiratory failure, with fewer than 2 weeks of new pulmonary symptoms;
- •Endotracheal intubation or tracheostomy;
- •Hypoxaemia - defined as a PaO2/FiO2 ≤ 200 mm Hg;
- •Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph
排除标准
- •Remaining duration of mechanical ventilation < 48 hours, as judged by the attending physician;
- •Primary cause of acute respiratory failure judged by attending physician to be cardiac in origin;
- •Lack of commitment to ongoing life support;
- •Weight < 35 kg;
- •Severe chronic respiratory disease
- •Morbid obesity - defined as > 1 kg / cm body height;
- •Neurological conditions with risk of intracranial hypertension (hypercapnia should be avoided);
- •Neuromuscular disease that will result in prolonged need for mechanical ventilation;
- •Previous enrolment in this trial;
- •All inclusion criteria present for > 72 hours;
- •On HFO at the time of screening.
结局指标
主要结局
adherence to our explicit mechanical ventilation protocols;
时间窗: duration of mechanical ventilation
to measure and understand the reasons for crossovers between groups
时间窗: duration of mechanical ventilation
to estimate the rate of patient recruitment, and understand barriers to recruitment
to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment
次要结局
未报告次要终点