Free Tissue Flaps Clinical Trial
Official title:
Pleth Variability Index Based Intraoperative Fluid Management in Head and Neck Free Flap Reconstructive Surgeries
Verified date | April 2017 |
Source | Rajiv Gandhi Cancer Institute & Research Center, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rajiv Gandhi Cancer Institute & Research Center, India |
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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