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

NCT03116178 | Completed DMC

• 1 other identifier: RGCI ID:503/AN/ITC-02
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Free Tissue Flaps

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in TEG waveform tracing as obtained from TEG 5000 Hemostasis analyser system

  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

Study Arms (2)

Group B

ACTIVE COMPARATOR

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

Group G

ACTIVE COMPARATOR

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

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

Interventions

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

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

Group G

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

Intravenous fluid @6-8ml.kg and blood loss replacement with colloids maintaining urine output of 0.5ml/kg

Group B

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing radial and anterolateral free flap

You may not qualify if:

• Duration of surgery \> 6hrs
• BMI \> 30
• Patients on anti platelet drugs
• Patient refusal

Sponsors & Collaborators

• Rajiv Gandhi Cancer Institute & Research Center, India: lead

Related Publications (2)

• Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.

  PMID: 20705785 BACKGROUND

• Yu Y, Dong J, Xu Z, Shen H, Zheng J. Pleth variability index-directed fluid management in abdominal surgery under combined general and epidural anesthesia. J Clin Monit Comput. 2015 Feb;29(1):47-52. doi: 10.1007/s10877-014-9567-5. Epub 2014 Feb 21.

  PMID: 24557584 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr (senior consultant)

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: April 14, 2017
• Study Start: March 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share