Pleth Variability Index Based Intraoperative Fluid Management in Head and Neck Free Flap Reconstructive Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Changes in TEG waveform tracing as obtained from TEG 5000 Hemostasis analyser system
研究概览
简要总结
Intraoperative fluid given according to BMI in group B and according to pulse oximeter- derived pleth variability index(MASIMO RAINBOW PULSE CO OXIMETRY) in group G. Comparison of haemodynamics, urine output,blood lactate levels, blood sugar, flap sugar and coagulation profile between the two groups.
详细描述
A sample size of 80 taken and computer generated random allocation done to divide the patients in two groups(40 each). Head and neck onco surgery patients undergoing resection and reconstruction with radial artery free flap and antero lateral thigh free flap of duration 4-6 hours taken for surgery.
Group B to receive intravenous fluid according to body weight stating at the rate 6-8 ml/kg/hr.
Group G to receive intravenous fluid according to Pleth variability index value(4-11).Blood loss up to 10% replacement by colloids.
Comparison of following parameters:
Demography, haemodynamics,urine output .blood lactate, ph, oxygenation index ,thromboelastography (TEG), blood sugar, flap sugar .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing radial and anterolateral free flap
排除标准
- •Duration of surgery > 6hrs
- •BMI > 30
- •Patients on anti platelet drugs
- •Patient refusal
结局指标
主要结局
Changes in TEG waveform tracing as obtained from TEG 5000 Hemostasis analyser system
时间窗: six months
The investigators hypothesize that the patients in group G receiving PVI (pleth variability index) guided fluid therapy will have normal TEG parameter (R,K, ALPHA, MA and LY30) values and the patients in group B may have abnormal TEG parameter values.
次要结局
未报告次要终点
研究者
DR ITEE CHOWDHURY
Dr (senior consultant)
Rajiv Gandhi Cancer Institute & Research Center, India