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

Rajiv Gandhi Cancer Institute & Research Center, India

Status: Completed

Conditions: Free Tissue Flaps

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03116178

RGCI ID:503/AN/ITC-02

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 80 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Group B

Active Comparator group

Description:

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.

Treatment:

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

Group G

Active Comparator group

Description:

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

Treatment:

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