Non-invasive Ventilation Prevents Post-operative Respiratory Failure in Patient Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Intensive care unit admission rate
研究概览
简要总结
Postoperative non-invasive ventilation (NIV) has been proposed as an attractive strategy to reduce morbidity and improve postoperative outcomes in obese subjects undergoing general anesthesia. Bariatric patients present a peculiar negative feature; the increased body mass index (BMI) correlates with loss of perioperative functional residual capacity (FRC), expiratory reserve volume (ERV) and total lung capacity (TLC), decreased up to 50% of preoperative values. The aim of the current randomized trial is to evaluate the efficacy of NIV in post-anaesthesia care unit (PACU) in reducing post-extubation acute respiratory failure and the consequent admission in intensive care units (ICU) after BIBP in obese adult patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Morbid Obesity
- •Patients undergoing Biliointestinal Bypass (BIBP)
排除标准
- •Patients requiring emergency operation with rapid sequence induction
- •Patients with suspected presence of difficult airway or pre-existing lung impairment
- •Pregnancy
- •Severe renal dysfunction,
- •cardiac disease resulting in marked limitation of physical activity, corresponding to NYHA class >II
结局指标
主要结局
Intensive care unit admission rate
时间窗: 72 hours
The primary outcome was the evaluation of the ICU admission rate after NIV in postoperative management of obese patients
Blood oxygen saturation (SaPo2)
时间窗: 12 hours
the evaluation of the oximetry values of obese patients after postoperative NIV adoption
次要结局
未报告次要终点
研究者
Claudio Gambardella
Clinical Professor
University of Campania "Luigi Vanvitelli"