Ventilation Strategy During General Anesthesia for Orthopedic Surgery: A Quality Improvement Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,860
- 试验地点
- 2
- 主要终点
- Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU)
研究概览
简要总结
The objective is to determine the optimal intraoperative ventilation strategy among the chosen tidal volume and positive end-expiratory pressure (PEEP) levels, and standardize it in an enhanced recovery pathway for orthopedic surgical patients. In particular, we propose to determine which combination of intraoperative tidal volume and positive end-expiratory pressure is best for patients having elective orthopedic surgery.
详细描述
This is a non-randomized alternating intervention cohort study in which all orthopedic surgery operating rooms will alternate amongst four designated ventilation settings which include two tidal volumes and two PEEP levels. At the end of the four-week sequence, the entire sequence will be repeated 26 times over a 2-year period. Thus, ventilator settings will not be randomized on a per-patient basis, or even among study weeks.
Ventilation parameters will be designated at the beginning of each study week. However, clinicians will be free to adjust to whatever ventilation settings they believe is optimal in individual patients to ensure oxygenation and patient safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Surgery in orthopedic operating rooms 32-37
- •General anesthesia with endotracheal intubation.
排除标准
- •Non-orthopedic procedures;
- •Intubation before induction of anesthesia.
结局指标
主要结局
Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU)
时间窗: After surgery until discharged from PACU or up to 90 minutes
Primary outcome was oxygenation in the postoperative care unit, defined by the peripheral oxygen saturation divided by the fraction of inspired oxygen (SpO2/FiO2 ratio), a validated measure of acute lung injury.
次要结局
- Composite of Serious Postoperative Pulmonary Complications(After surgery from 2 to 5 days)
- Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio(After surgery from 2 to 5 days)
- Length of Postoperative Hospital Stay by Days(from out of operation room to discharge)