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

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ClinicalTrials.gov Identifier: NCT03116178
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
DR ITEE CHOWDHURY, 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.

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

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 .


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Arm Intervention/treatment
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





Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications:
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Responsible Party: DR ITEE CHOWDHURY, Dr (senior consultant), Rajiv Gandhi Cancer Institute & Research Center, India
ClinicalTrials.gov Identifier: NCT03116178     History of Changes
Other Study ID Numbers: RGCI ID:503/AN/ITC-02
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by DR ITEE CHOWDHURY, Rajiv Gandhi Cancer Institute & Research Center, India:
Fluid therapy
oximetry
thromboelastography
intraoperative/method
monitoring