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

April 13, 2017 updated by: DR ITEE CHOWDHURY, Rajiv Gandhi Cancer Institute & Research Center, India

Pleth Variability Index 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

November 11, 2016

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RGCI ID:503/AN/ITC-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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