Preoperative Ultrasound-based Protocol for Optimization of Fluid Therapy to Prevent Hypotension Associated to General Anesthesia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Rate of hypotension associated to general anesthesia induction
研究概览
简要总结
Background: Intraoperative hypotension increases 30-day mortality and the risks of myocardial injury and acute renal failure. Patients with inadequate volume reserve before the induction of anesthesia are highly exposed. The identification of latent hypovolemia is therefore crucial. Ultrasonographic measurement of the inferior vena cava collapsibility index (IVCCI) is able to detect volume responsiveness in circulatory shock and growing evidence support the theory that higher IVCCI can predict intraoperative hypotension.
The aim of the present study is to evaluate the potential benefit of an ultrasound-based protocol for preoperative fluid optimization. The investigators will perform a randomized-controlled study involving elective surgical patients. An ultrasound-based protocol (USP) arm and a conventional fluid therapy group (CFT) are to be formed. Ultrasound examinations will be performed twice in both groups: 2 hours and 30 minutes preoperatively. The inferior vena cava and the anterior lung fields will be scanned. In the USP group the participants will receive fluid therapy according to the ultrasonographic findings: high level of IVCCI and absence of signs of pulmonary edema will indicate fluid therapy. In the CFT group the attending anesthesiologist (blinded to the results of ultrasonography) will order fluid therapy on the basis of daily routine and clinical judgement.
The investigators will evaluate the incidence of intraoperative hypotension (primary outcome), postoperative metabolic status and organ functions and the amount of the administered intravenous fluids in both groups.
详细描述
A randomized-controlled study with 80 participants.
The investigators will use computer-generated unpaired random allocation method to an ultrasound-based protocol (USP) group or to the conventional fluid therapy (CFT) group.
Preoperative ultrasound examinations will be performed twice in both groups: 2 hours and 30 minutes preoperatively. The inferior vena cava and the lung fields (so called BLUE - Bedside Lung Ultrasound in Emergency - points: 2nd or 3rd intercostal space anterior, 5th-6th interspace anterior and posterior axillary line position) will be scanned. The collapsibility index (IVCCI) of the IVC is calculated, >40 percent is considered 'high IVCCI'. Lung ultrasound (LUS) is evaluated as indicative for 'lung congestion' if symmetric anterior B-profiles (at least 3 B-lines in anterior lung fields) are detected.
Baseline demographic (age, sex, height, weight) and comorbidity data (history of hypertension, chronic heart failure, coronary or cerebrovascular disease, respiratory illness e.g. COPD, past COVID, diabetes on insulin treatment) together with laboratory data (haemoglobin, creatinine, blood urea) are to be recorded.
A standardized practice of monitoring and induction of general anesthesia will allow for the detection of immediate and early (first 10 minutes of anesthesia) hypotensive events. A follow up for 24 hours is necessary for evaluating the fulfillment of secondary endpoints. A semi-quantitative lung ultrasound after 24 hours will estimate lung aeration.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The attending anesthesiologist, participant and outcomes assessors will be blinded to randomization and result of preoperative ultrasound scans. The attending anesthesiologist (not aware of randomization and ultrasonographic findings) gives a dose recommendation for fluid therapy for all patients. The investigator will be aware of the randomization and ultrasound results. This investigator will choose the fluid therapy (conforming to the ultrasound based protocol OR to the dose-recommendation of the attending anesthesiologist) following the results of randomization and ultrasound scans in the USP group.
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
- •Elective surgery
- •General surgical procedures
- •Estimated duration of anesthesia > 60 minutes
- •ASA class 2 or 3
排除标准
- •Emergency procedure
- •Reoperation, redo procedure
- •Patient who is incapable of acting
- •Uncontrolled hypotension (<90 mmHg)
- •Uncontrolled hypertension (>180 mmHg)
- •High risk valvular disease (Aortic Stenosis)
- •Endocrine hypertension (Conn's syndrome, phaeochromocytoma)
- •Sepsis (infection and SOFA≥2 pt)
- •Conditions blocking lung ultrasound (pneumothorax without drainage, former pulmonary resection, pleural effusion affecting more than 2 interspaces)
- •Pregnancy
结局指标
主要结局
Rate of hypotension associated to general anesthesia induction
时间窗: first 10 minutes of anesthesia
mean arterial pressure \< 65 mmHg AND/OR ≥30 percent of decrease compared to baseline (before induction of anesthesia)
次要结局
- Dose of preoperative fluid therapy (in millilitres)(preoperative time frame on the day of surgery)
- Dose fluid therapy of the operative day (in millilitres)(24 hours)
- lactate level (mmol/l)(1st postoperative hour)
- base excess (mmol/l)(1st postoperative hour)
- urine output (millilitres/24 h)(24 hours)
- lung ultrasound score (LUS)(24th postoperative hour)
研究者
Marcell Szabo
assistant lecturer
Semmelweis University