NCT02158923已完成不适用
Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation. A Comparative, Prospective, Multicenter, Randomized Controlled Trial.
Fundación para la Investigación del Hospital Clínico de Valencia13 个研究点 分布在 4 个国家目标入组 920 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 920
- 试验地点
- 13
- 主要终点
- Reduction of lung and systemic postoperative complications
研究概览
简要总结
The purpose of this study is to determine whether individualized ventilatory management combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and postoperative individualized ventilatory support will decrease postoperative complications, unplanned ICU readmissions, ICU and hospital length of stay and mortality compared to a standardized Lung Protective Ventilation (LPV) for all patients at risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age not less than 18
- •Risk of postoperative pulmonary complication moderate-high defined by a score ≥ 26 on the risk scale ARISCAT (based on the analysis of seven factors, where a score between 26 and 44 points defines a moderate risk, and a score> 44 points define a high risk, included in the Information Booklet Investigator).
- •Planned abdominal surgery> 2 hours.
- •Signed informed consent for participation in the study.
排除标准
- •Age less than 18 years.
- •Pregnant or breast-feeding.
- •Patients with BMI >
- •Syndrome of moderate or severe respiratory distress: PaO2/FiO2 < 200 mmHg.
- •Heart failure: NYHA IV.
- •Hemodynamic failure: CI <2.5 L/min/m2 and / or requirements before surgery ionotropic support.
- •Diagnosis or suspicion of intracranial hypertension (intracranial pressure> 15 mmHg).
- •Mechanical ventilation in the last 15 days.
- •Presence of pneumothorax. Presence of giant bullae on chest radiography or computed tomography (CT).
- •Patient with preoperatively CPAP.
- •Participation in another experimental protocol at the time of intervention selection.
结局指标
主要结局
Reduction of lung and systemic postoperative complications
时间窗: Up to 7 postoperative days
次要结局
- Reduction of lung and systemic postoperative complications(Up to 30 postoperative days)
研究者
Carlos Ferrando
MD, PhD
Fundación para la Investigación del Hospital Clínico de Valencia
研究点 (13)
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