Preoperative Rapid Pou Ultrasound（Pre-operative Ultrasound Evaluation Protocol） Assessment of Randomized Controlled Clinical Trials for Optimal Management of Anesthesia in Critically Ill Patients Undergoing Emergency Surgery.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Severe complication rate
研究概览
简要总结
With the development of society, the number of emergency critical operations is increasing year by year. Traditionally, the patient's systemic and circulatory status is indirectly assessed by testing and blood pressure heart rate. There are cases where the diagnosis is imperfect and the results are unreliable. Preoperative POU rapid ultrasound is a preoperative bedside ultrasound evaluation method first proposed by the Anesthesiology Department of Huaxi Hospital (three engineering units). This project will cooperate with Huaxi Hospital to explore whether the effect of intraoperative anesthesia management under POU guidance is better than traditional anesthesia management. This study will provide a new preoperative evaluation anesthesia management program for emergency critically ill patients with important clinical and social significance.
详细描述
According to the inclusion and exclusion criteria, the patients will be randomly divided into two groups：In the control group, the anesthesiologist performed according to the existing preoperative evaluation program and existing experience, and guided the anesthesia management with the evaluation results.The experimental group used POU protocol ultrasound to perform a heart scan and a standard scan, a large vascular scan under the xiphoid, a body cavity scan, a standard section, and a lung scan in 10 minutes. Comprehensive preoperative circulation and assessment of systemic conditions, and guided intraoperative anesthesia management with assessment results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Volunteers and data collectors was masked
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.pulse oxygen saturation (spO2) ≤ 92% when inhaling air.
- •2.respiratory frequency ≥ 20 beats / min.
- •3.systolic blood pressure (sbp) <90mmHg.
- •4.heart rate (hr)>100 times/min.
- •5.requires positive inotropic drugs and/or vasopressors.
- •6.need artificial ventilation.
- •7.Signing informed consent.
排除标准
- •1.age <14 years old.
- •2.unable to perform ultrasound evaluation (bandage, clam shell).
- •3.participated in other clinical trials in the first 3 months of the study.
- •4.researchers believe that it is not appropriate to include this tester.
- •5.any reason can not cooperate with this study.
- •6.cardiac surgery patient
- •7.organ transplant patient.
- •8.obstetric surgery patient.
- •9.you can start rescue after entering the room (such as CPR, etc.), and you are not allowed to perform ultrasound scans.
研究组 & 干预措施
POU ultrasound intervention test group
The experimental group used POU protocol ultrasound to perform a heart scan and a standard scan, a large vascular scan under the xiphoid, a body cavity scan, a standard section, and a lung scan in 10 minutes. Comprehensive preoperative circulation and assessment of systemic conditions, and guided intraoperative anesthesia management with assessment results.
干预措施: POU protocol ultrasound (Device)
Control group
the anesthesiologist performed according to the existing preoperative evaluation program and existing experience, and guided the anesthesia management with the evaluation results.
结局指标
主要结局
Severe complication rate
时间窗: The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years
Serious complications include cardiac arrest, respiratory failure, hemorrhagic shock, pulmonary embolism, etc.
Subjects' health status scores 30 days, 90 days, half a year, and one year after surgery.
时间窗: The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years
Follow-up was performed 30 days, 90 days, half a year, and one year after surgery, and the patient's prognosis was assessed using a health score sheet.
mortality rate
时间窗: The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years
The number of patients who died from any cause since the date of randomization.
次要结局
未报告次要终点