NCT03116178

PVI Based Intraoperative Fluid Management in Head and Neck Free Flap Reconstructive Surgeries

Pleth Variability Index Based Intraoperative Fluid Management in Head and Neck Free Flap Reconstructive Surgeries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 .

Conditions

• Free Tissue Flaps

Interventions

Type	Name	Description
OTHER	Group G -PVI( Masimo co oximeter) guided fluid therapy	goal directed fluid therapy maintaining pvi 4-11. when pvi\<4 fluid rate is 50-60ml/hr and pvi\>11 200ml colloid bolus transfusion till pvi value achieves normal range. In the control group crystalloid was administered @ 6-8 ml/kg and blood loss was replaced by colloids. Hourly urine output was measured and if less than 0.5ml/hr bolus crystalloid 100-200ml was administered
OTHER	Group B- Body weight guided intravenous fluid @6-8ml/kg	Intravenous fluid @6-8ml.kg and blood loss replacement with colloids maintaining urine output of 0.5ml/kg

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2017-04-14
• Last updated: 2017-04-14