Effect of Intraoperative Fluid Management Guided by Respiratory Variations of Internal Jugular Vein on Postoperative Complications in Abdominal Surgeries: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- The primary outcome is the incidence of postoperative complications in both groups, which will be measured by the occurrence of any of the postoperative complications during the first seven postoperative days in both groups
研究概览
简要总结
This study investigates the role of respiratory variation in the internal jugular vein as a tool for intraoperative fluid management during abdominal surgeries under general anesthesia.
The purpose of this clinical trial is to reduce postoperative complications and improve patient outcomes through proper intraoperative fluid management.
The main question it aims to answer is: Can intraoperative fluid management guided by the respiratory variation of the internal jugular vein during abdominal surgeries reduce postoperative complications? Research Hypothesis (Alternative Hypothesis): We hypothesize that fluid management guided by the respiratory variation of the internal jugular vein during abdominal surgeries can reduce postoperative complications.
The patients will be divided into two groups and randomized to receive either intraoperative fluid therapy guided by the respiratory variation of the internal jugular vein or standard fluid therapy. Postoperative complications, length of hospital stay, total amount of fluid administered intraoperatively, use of vasopressors in both groups, and incidence of hypotensive episodes will be recorded.
详细描述
Sonographic measurement of respiratory variation of IJV will be performed with a Philips CX50 ultrasound device (Philips Healthcare, Hamburg, Germany), equipped with a linear transducer. Respiratory variation of IJV will be measured by the same anesthesiologist with sufficient experience in ultrasound guided IJV cannulation. The anesthesiologist performing the ultrasound examinations will not be involved in this study and blinded to the hemodynamic parameters; a lead plate separated the monitor from the anesthesiologist and ultrasound device. The optimal short axis of the IJV will be obtained at the level of the cricoid cartilage by placement of the transducer perpendicular to the skin on the patient's neck in a transverse plane. The vein will be identified with color Doppler imaging as well as by compression. Ultrasound measurements will be performed on the left IJV, M-mode scan will be used to record the IJV diameter at the end of inspiration (IJVmax) and expiration (IJVmin) over an entire respiratory cycle. The images will be then frozen. The respiratory variation of IJV will be calculated with the following formula: IJV RV (%) = (IJVmax - IJVmin)/ (IJVmin) × 100%. The average values of IJVmax and IJVmin from three consecutive respiratory circles will be used in the analysis.
The finding of a small-diameter IJV (<1cm) and increased IJV RV (>18) suggest low-volume states. Conversely, a large IJV diameter (>2.1cm) and decreased IJV RV (<18) will suggest a high-volume state.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' American Society of Anesthesiologists physical status (ASA) is I and II.
- •The target age group is 20 to 70 years old.
- •Patients scheduled for abdominal surgery under general anesthesia with normal renal function.
排除标准
- •Refusal of the procedure or participation in the study.
- •Coagulopathy.
- •Pre-existing cardiac, renal, and respiratory diseases. 4-Internal jugular vein thrombosis
研究组 & 干预措施
Internal Jugular Vein (IJV) group (Study group)
In this group, fluid therapy will be guided by the respiratory variation of IJV throughout the surgery.
干预措施: Respiratory variation of the Internal Jugular Vein (IJV) (Diagnostic Test)
Control group
In this group, conventional fluid therapy will be given to ensure that the mean arterial blood pressure is equal to or more than 65 mmHg.
结局指标
主要结局
The primary outcome is the incidence of postoperative complications in both groups, which will be measured by the occurrence of any of the postoperative complications during the first seven postoperative days in both groups
时间窗: The first seven postoperative days
Postoperative complications will include: (i) infections (urinary tract infection, wound infection, sepsis/septic shock) (ii) GI (Ileus, acute bowel obstruction, GI bleeding, abdominal compartment syndrome), (iii) Cardiovascular (deep venous thrombosis, pulmonary embolism, myocardial ischemia or infarction, cardiac arrest), (iv) Renal (AKI) (v) Respiratory (pneumonia, prolonged mechanical ventilation (more than 24 hours), respiratory failure, ARDS).
次要结局
- Intraoperative vasopressor use in both groups(Intraoperatively (From the start to the end of the surgery))
- Intraoperative hypotensive episodes in both groups(Intraoperatively (From the start to the end of the surgery))
- Assessment of the total amount of fluid administered intraoperatively in both groups(Intraoperatively (From the start to the end of the surgery))
- The length of hospital stay in both groups(Up to 30 days postoperatively.)
研究者
Mohammad E Salama, MD
Principal investigator
Suez Canal University