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Clinical Trials/NCT03116178
NCT03116178
Completed
Not Applicable

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

Rajiv Gandhi Cancer Institute & Research Center, India0 sites80 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Free Tissue Flaps
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Enrollment
80
Primary Endpoint
Changes in TEG waveform tracing as obtained from TEG 5000 Hemostasis analyser system
Status
Completed
Last Updated
9 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
October 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Responsible Party
Principal Investigator
Principal Investigator

DR ITEE CHOWDHURY

Dr (senior consultant)

Rajiv Gandhi Cancer Institute & Research Center, India

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in TEG waveform tracing as obtained from TEG 5000 Hemostasis analyser system

Time Frame: 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.

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