PVI Based Intraoperative Fluid Management in Head and Neck Free Flap Reconstructive Surgeries
NCT ID: NCT03116178
Last Updated: 2017-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
80 participants
INTERVENTIONAL
2016-03-31
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Stroke Volume Variation and Plethysmography Variability Index as Goal Directed Fluid Therapy in Major Oncosurgeries
NCT05142163
Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction
NCT06080178
Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery
NCT01129037
Two Cut-Off Values of Plethysmographic Variability Index to Guide Intraoperative Fluid Therapy on Serum Lactate in Patients Undergoing Excision of Supra-Tentorial Brain Tumors
NCT07174128
Pleth Variability Index and Fluid Management During Surgery
NCT00816153
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 .
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
Group G
Group G- intervention - PVI( Masimo co oximeter) guided fluid therapy.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* BMI \> 30
* Patients on anti platelet drugs
* Patient refusal
25 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rajiv Gandhi Cancer Institute & Research Center, India
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
DR ITEE CHOWDHURY
Dr (senior consultant)
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RGCI ID:503/AN/ITC-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.