Prone-Supine Study II: The Effect of Prone Positioning for Patients Affected by Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 344
- 试验地点
- 17
- 主要终点
- Mortality
研究概览
简要总结
The purpose of this study is to determine whether prone positioning is effective in improving survival in patients affected by acute respiratory distress syndrome (ARDS).
详细描述
BACKGROUND: The beneficial effect of prone positioning on arterial oxygenation has been well demonstrated in ALI/ARDS patients. Moreover prone positioning has an impact on the distribution of the lung densities. Finally, after a period of prone position, the respiratory compliance and the arterial oxygenation markedly improve compared to the pre-pronation values. Overall, these evidences suggests that the prone positioning may affect the outcome of ARDS patients. Recently we reported the effect of prone positioning on the outcome of ARDS patients. In this study the treatment consisted of 6 hours of pronation daily for the first ten days after the onset of acute respiratory failure. Although we did not find any difference of outcome in the general population of ARDS patients (at ten days, at discharge from ICU and after 6 months), a post hoc analysis identified a reduction in mortality at the end of the 10-days treatment period in the quartile of patients affected by most severe ARDS. A critical analysis of some of the methodological weaknesses of the previous study, together with the new information emerging from other studies, led to the adoption of major changes in the overall conception as well as in the operational design of the protocol:
- a substantial prolongation of the daily exposure to the prone position (from 6 up to a minimum of 20 hours);
- the abolition of a time window for the duration of treatment, which is not stopped except in coincidence with weaning of the patient;
- a predefined scheme for applying mechanical ventilation in both groups, based on the "lung protective strategy" concept.
OBJECTIVE: To assess the effect of prone positioning on mortality in ARDS patients, stratified at randomization according to predefined criteria of severity of respiratory failure.
STUDY DESIGN: This is a randomized, controlled, multi-center study. The patients will be randomized in two groups:
- Controls will receive optimised standard intensive treatment, including protective ventilatory strategy;
- Treatment: extended (at least 20 hrs) daily prone positioning is added to control treatment.
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
- Single (Participant)
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 receiving mechanical ventilation will be enrolled if they meet criteria for acute respiratory distress syndrome, with the PaO2/FiO2 ratio criterion modified as follows:
- •PaO2/FiO2 ratio ≤ 200 with 5 ≤ PEEP ≤ 10 cmH2O
排除标准
- •Age < 16 years.
- •> 72 hours since all inclusion criteria are met.
- •Lung transplant, liver transplant or bone marrow transplant.
- •Clinical or instrumental evidence of cerebral edema or elevated endocranial pressure.
- •Conditions which are thought to contraindicate the use of prone positioning (i.e., not-stabilized bone fracture, column fracture, pelvis fracture, multiple rib fracture with chest-wall instability, severe haemodynamic instability).
结局指标
主要结局
Mortality
时间窗: at 28 days
次要结局
- Ventilator-free days(ICU discharge)
- Number of days without respiratory failure(ICU discharge)
- Number of days of dysfunction for each organ system and cumulative dysfunction (sequential organ failure assessment [SOFA] score)(ICU discharge)
- Mortality(at ICU discharge, at 6 months)