Ultrasound Lung Evaluation of Different Fluid Management Protocols in Patients Undergoing Laparoscopic Hysterectomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The rate of lung ultrasound B lines appearance.
研究概览
简要总结
Bedside lung ultrasound can detect pulmonary congestion by detecting the appearance of B-lines. Pulmonary edema may occur even without cardiomyopathy or heart failure, especially after excessive fluid administration. B-lines have been acknowledged as sonographic signs of pulmonary interstitial and alveolar edema in critical and emergency care. Limited scientific evidence on optimal intraoperative fluid management has resulted in large variations of administered fluid regimens in daily practice. The restricted perioperative intravenous fluid regimen reduces complications after elective surgeries, however other studies had shown that intraoperative liberal fluid administration improves postoperative organ functions and recovery and shortens hospital stay after elective surgeries.
详细描述
A review of patients undergoing major abdominal surgery, excluding high-risk patients, compared liberal and restrictive fluid regimens; concluded that it is difficult to define 'liberal' or 'restrictive' protocols in clinical practice. patients undergoing moderate-risk surgery seem to benefit from the more liberal fluid administration, while patients undergoing high-risk or major surgery seem to benefit from restrictive or conservative strategies. Lung ultrasound used for comparison between liberal and restrictive fluid therapy in laparoscopic hysterectomy patients by detecting the B-lines intraoperatively or immediately postoperatively. The aim is to evaluate the lung ultrasound as a guide for intraoperative fluid management, being an index for increased extravascular lung water (ECLW). This operation is a moderately complex procedure that implies the Trendelenburg position. This position - in addition to liberal fluids - will increase venous return and increase the challenge on the cardiac muscle under anesthesia in these patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients scheduled for an elective laparoscopic hysterectomy.
- •American society of anesthesiologists status I-II.
排除标准
- •Patient refusal.
- •Severe cardiac insufficiency (New York Heart Association IV, myocardial infarction 3 months).
- •Valvular heart diseases.
- •Renal insufficiency (GFR<60 ml/kg/1.73m2).
- •Hepatic insufficiency (Albumin less than 3).
- •Patient with previous or current history of pulmonary disease.
- •History of allergy to anesthetic drugs.
- •Obese patients (BMI>30).
研究组 & 干预措施
Liberal fluid group
received 30 ml/Kg/h crystalloid for maximum 3 hours.
干预措施: 30 ml/Kg/h crystalloid (Drug)
Restrictive fluid group
received 10 ml /Kg/h crystalloids for maximum 3 hours.
干预措施: 10 ml/Kg/h crystalloid (Drug)
结局指标
主要结局
The rate of lung ultrasound B lines appearance.
时间窗: 5 minutes after the end of surgery.
Three or more comet lines appearance in a lung field. Two or more positive regions per side suggested a B-pattern. B -lines are defined as discrete laser-like vertical hyper-echoic artifacts that arise from the pleura line extend to the bottom of the screen without fading and move synchronously with lung sliding.
次要结局
- The total volume of crystalloid infusion.(Intraoperative.)
- The total volume of blood transfusion.(Intraoperative.)
- The amount of blood loss.(Intraoperative.)
- Central venous pressure(Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.)
- Serum sodium level.(15 minutes preoperative, 15 minutes postoperative.)
- Hemoglobin level.(15 minutes preoperative, 15 minutes postoperative.)
- Hematocrit value.(15 minutes preoperative, 15 minutes postoperative.)
- Mean blood pressure(Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.)
- Heart rate.(Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.)
- Peripheral oxygen saturation.(Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.)
- Serum potassium level.(15 minutes preoperative, 15 minutes postoperative.)
- The duration of surgery.(intraoperative.)
- Hourly urine output.(intraoperative,)
- Arterial blood gases.(15 minutes preoperative, 15 minutes postoperative.)
研究者
Alaa Mazy
associate professor of anesthesia and surgical intensive care
Mansoura University