Effectiveness of Peripheral Perfusion Index Guided Strategies for the Prevention and Treatment of Hypotension: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- time-weighted average of hypotension (TWA)<65mmHg
研究概览
简要总结
Intraoperative hypotension is closely related to the poor prognosis of surgery. The study is focused on the effectiveness of maintaining normal peripheral perfusion index (PPI) on time-weighted average of hypotension during anesthesia.
详细描述
Intraoperative hypotension is closely related to the poor prognosis of surgery. Hypotension decreased blood flow perfusion of organs, which lead to dysfunction of multiple organs, especially increasing serious complications such as cardio-cerebrovascular events and acute renal injury within 30 days after surgery. The aim of this study is to establish a set of strategies that can effectively prevent and treat intraoperative hypotension, so as to alleviate possible harm to patients from perioperative hypotension. The study is focused on the effectiveness of maintaining normal peripheral perfusion index (PPI) on time-weighted average of hypotension during anesthesia. The lower target mean arterial pressure (MAP) was higher than 65 mmHg. MAP less than 65 mmHg was defined as intraoperative hypotension between induction and tracheal extubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years and older ASA Physical Status 1-3 general anesthesia arterial catheterization procedures last more than 2 hours communicate normally in Mandarin
排除标准
- •abnormal Allen's test higher target than 65 mmHg history of diabetes vascular diseases arrhythmia cardiac function class II and above physical disability, unable to conduct PPI monitoring participated in other clinical studies in the past month
结局指标
主要结局
time-weighted average of hypotension (TWA)<65mmHg
时间窗: Intraoperative (between anesthesia induction and tracheal extubation)
total area under MAP\<65 mmHg/surgery length
次要结局
- Rate of hypotension after anesthesia induction(from anesthesia induction to 15 minutes after then)
- Cumulative number of intraoperative hypotension episodes(Intraoperative (between anesthesia induction and tracheal extubation))
- Proportion of time with hypotension(Intraoperative (between anesthesia induction and tracheal extubation))
- Cumulative time of intraoperative hypotension period(Intraoperative (between anesthesia induction and tracheal extubation))
- Cumulative number of intraoperative hypertension episodes(Intraoperative (between anesthesia induction and tracheal extubation))
- time-weighted average of hypertension (TWA)>100mmHg(Intraoperative (between anesthesia induction and tracheal extubation))
- postoperative plasma concentration of lactic acid(5 minutes before and 5 minutes after the end of surgery)
- intraoperative urine output(Intraoperative (between anesthesia induction and tracheal extubation))
- arterial partial pressure of oxygen (PaO2)/inspired fraction of oxygen (FiO2)(5 minutes before and 5 minutes after the end of surgery)
- the rate of acute kidney injury (AKI)(within 7 days after the end of surgery)
研究者
zhiqiang zhou
Principal Investigator
Tongji Hospital