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

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Free Tissue Flaps

Intervention / Treatment
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* Other: Group G -PVI( Masimo co oximeter) guided fluid therapy
* Other: Group B- Body weight guided intravenous fluid @6-8ml/kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group B<br>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. | Other: Group B- Body weight guided intravenous fluid @6-8ml/kg<br>* Intravenous fluid @6-8ml.kg and blood loss replacement with colloids maintaining urine output of 0.5ml/kg<br>|
| Active Comparator: Group G<br>Group G- intervention - PVI( Masimo co oximeter) guided fluid therapy. | Other: Group G -PVI( Masimo co oximeter) guided fluid therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in TEG waveform tracing as obtained from TEG 5000 Hemostasis analyser system | 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. | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid therapy, oximetry, thromboelastography, intraoperative/method, monitoring