Evaluation of Non Invasive Methods for Goal Directed Fluid Therapy During Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- ml colloid infusion
研究概览
简要总结
Goal directed volume therapy means that bolus doses of 150-250 ml colloid fluid is administered to the patient during contemporary measurement of the patients stroke volume. The fluid status is considered optimized when stroke volume no longer increases with more than 10%, indicating that the patient is close to the top of the Frank-Starling curve. Several studies show that volume optimization reduces hospital stay and reduces the amount of surgical complications. The overall purpose is to investigate if the much more simple non invasive technique Pleth Variability Index can replace oesophageal doppler to guide volume therapy in routine health care, and to analyse if a volume kinetic test can be used to evaluate hypovolemia before surgery and make specific rehydration possible by analysing the correlation between this test and fluid optimization using stroke volume measurements.
Primary hypothesis: 1. The volume of colloids that is given to volume optimise an anesthetized patient using Pleth Variability Index shows a good correlation to the volume used if volume optimisation is undertaken by the guidance of oesophageal doppler. 2. Data from the two methods correlate and discriminates similarly volume responders from non responders. 3. A volume kinetic model that indicates dehydration can predict the need for rehydration in order to achieve a well hydrated patient at start of surgery.
详细描述
The patients are not allowed to eat after midnight. Routine premedication is given with paracetamol and oxynorm/oxycontin. Thrombosis and antibiotic prophylaxis is given according to surgical department.
The weight of the patient is notices on the morning of surgery (day 0).
The patient arrives in the morning to the preoperative area. A urinary analysis is taken for urinary colour, creatinine, specific weight, osmolality, microalbuminuria and electrolytes. For 30 patients a volume kinetic analysis of 5 ml/kg infusion of acetated Ringers solution is undertaken between 6.30 and 8.00 am on the morning of surgery. During 15 minutes 5 ml/kg acetated Ringers solution is infused intravenously. Hb is continuously measured noninvasively by Masimo Radical 7 pulse oximeter (MasimoHb) and invasively with maximum 13 samples a 4 ml during 80 minutes (0, 10, 15, 25, 40, 50, 60 and 70 min. Double samples at start and 60 min. The volume kinetic part of the study is finished after 70 min when the patient urinates and the volume is measured.
The patient is taken to the operating theatre and MasimoHb, NT-proBNP, Troponin T hs, pl-lactate, PI och PVI (stable value during 5 min) is registered before anaesthesia. Avoid having blood pressure cuff and pulse oximeter for PVI analysis on the same arm. Aim at PI > 1 to get a reliable registration of PVI, otherwise try another finger.
Anaesthesia: Epidural anaesthesia according to clinical praxis (activated after the first volume optimisation and kept activated during surgery) and anaesthesia according to clinical practise. The ventilation during anaesthesia is maintained using volume controlled mode, tidal volume 7 ml/kg (ideal weight, using the formula: men 50 + 0.91(height in centimetre -152.4); women 45.5 + 0.91(height in centimetre -152.4)), PEEP 5 - 10 cmH2O, respiratory rate to achieve normocapnia. Tidal volume and PEEP is maintained during surgery. The Doppler sond is placed after anaesthesia induction and after that the gastric sond is placed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Open abdominal surgery under general anaesthesia with a planned operation time of at least 120 minutes
- •Age ≥ 18 years
排除标准
- •Anaesthesia risk classification ASA ≥ 4
- •Arrhythmia; atrial fibrillation or multiple extra systoles
- •Aortic - or mitral insufficiency with hemodynamic influence
- •Patients who at the preoperative visit by the responsible anaesthesiologist is planned for a more advanced cardiovascular monitoring. The following monitoring is accepted in the study: invasive blood pressure, 5-lead ECG, central venous pressure and urinary output per hour.
- •Patients with a pulmonary or other disease that prevents ventilation using a tidal volume of 7 ml/kg (ideal weight) or a positive end expiratory pressure of 5 -10 cm H2O
- •Contra indication against synthetic colloids as severely impaired renal or liver function, hyper natremia or allergy to synthetic colloids
- •Laparoscopic surgery
- •Liver surgery
- •Surgery including thoracotomy
- •Contraindications against an oesophageal probe such as severe oesophageal varicose veins
结局指标
主要结局
ml colloid infusion
时间窗: During surgery (2-8 hours)
Volume colloid fluid to achieve volume optimisation for guidance using Pleth Variability Index and oesophageal doppler, respectively (comparison between groups)
Correlation between ml colloid infusion and dehydration level
时间窗: During surgery (2-8 hours)
Correlation between level of dehydration measured by volume kinetics and urinary analysis, and correlation between these two circumstantials and the volume of colloids given for the first volume optimisation using Pleth Variability Index or oesophageal doppler
次要结局
- Complications (number)(Complications occuring up to 30 days after surgery)
- NT-pro-BNP(Measured up to 2 days after surgery)
- Days(Days of hospital stay in connection with surgery, usually 2-10 days)
研究者
Lena Nilsson
Senior consultant, PhD
University Hospital, Linkoeping