PVI Based Intraoperative Fluid Management in Head and Neck Free Flap Reconstructive Surgeries
|ClinicalTrials.gov Identifier: NCT03116178|
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Free Tissue Flaps||Other: Group G -PVI( Masimo co oximeter) guided fluid therapy Other: Group B- Body weight guided intravenous fluid @6-8ml/kg||Not Applicable|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Pleth Variability Index Based Intraoperative Fluid Management in Head and Neck Free Flap Reconstructive Surgeries|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Active Comparator: Group B
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
Intravenous fluid @6-8ml.kg and blood loss replacement with colloids maintaining urine output of 0.5ml/kg
Active Comparator: Group G
Group G- intervention - PVI( Masimo co oximeter) guided fluid therapy.
Other: Group G -PVI( Masimo co oximeter) guided fluid therapy
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
- 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.