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

Not Applicable
Completed
Conditions
Free Tissue Flaps
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 .

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
Primary Outcome Measures
NameTimeMethod
Changes in TEG waveform tracing as obtained from TEG 5000 Hemostasis analyser systemsix 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.

Secondary Outcome Measures
NameTimeMethod

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