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

Not Applicable

Completed

• Conditions: Free Tissue Flaps
• Interventions: Other: Group G -PVI( Masimo co oximeter) guided fluid therapy; Other: Group B- Body weight guided intravenous fluid @6-8ml/kg

• Registration Number: NCT03116178
• Lead Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India

Brief 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 .

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-11-11
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-13
• Last Update Submitted: 2017-04-13
• Study First Posted: 2017-04-14
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All patients undergoing radial and anterolateral free flap

Exclusion Criteria

• Duration of surgery > 6hrs
• BMI > 30
• Patients on anti platelet drugs
• Patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group G	Group G -PVI( Masimo co oximeter) guided fluid therapy	Group G- intervention - PVI( Masimo co oximeter) guided fluid therapy.
Group B	Group B- Body weight guided intravenous fluid @6-8ml/kg	Group B- intervention -Body weight guided Intraoperative fluid administered @ 6-8 ml/kg and blood loss replacement with colloid. hourly urine output if less than 0.5ml/hr 100-200ml bolus of plasmalyte was administered.

Primary Outcome Measures

Name	Time	Method
Changes in TEG waveform tracing as obtained from TEG 5000 Hemostasis analyser system	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.