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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03116178

Enrollment

Registered

2017-04-14

Start date

2016-03-31

Completion date

2016-10-31

Last updated

2017-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Free Tissue Flaps

Keywords

Fluid therapy, oximetry, thromboelastography, intraoperative/method, monitoring

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.

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 .

Interventions

OTHERGroup 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

OTHERGroup 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in TEG waveform tracing as obtained from TEG 5000 Hemostasis analyser system	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026