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

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.

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Key information

Conditions

Free Tissue Flaps

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group G -PVI( Masimo co oximeter) guided fluid therapy

Other

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

Group B- Body weight guided intravenous fluid @6-8ml/kg

Other

Intravenous fluid @6-8ml.kg and blood loss replacement with colloids maintaining urine output of 0.5ml/kg

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.

Sponsors and collaborators

Lead sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Apr 14, 2017
Registry last updated: Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed