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Association of Pleth Variability Index Monitoring With Intraoperative Hemodynamic Control in Pediatric Craniosynostosis Surgery

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This prospective observational study aims to evaluate the role of pleth variability index (PVI) and perfusion index (PI) monitoring in intraoperative hemodynamic control among pediatric patients undergoing craniosynostosis surgery. Patients aged 0-6 years will be monitored intraoperatively using standard anesthesia monitoring together with PVI and PI measurements. Hemodynamic parameters, including systolic, diastolic and mean arterial pressure, heart rate, central venous pressure, oxygen saturation, body temperature, urine output, blood loss, fluid replacement, blood product requirement, serum lactate level, blood gas parameters and intraoperative complications will be recorded. The study will assess the association between PVI/PI changes and intraoperative hemodynamic status, bleeding and transfusion requirements.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 6
View:

• Pediatric patients aged 0 to 6 years

• Patients scheduled to undergo craniosynostosis surgery

• American Society of Anesthesiologists physical status I, II or III

• Written informed consent obtained from the parent or legal guardian

Locations
Other Locations
Turkey
Basaksehir Cam and Sakura City Hospital
RECRUITING
Istanbul
Contact Information
Primary
Muzaffer Gencer, associate professor
dr.m.gencer07@gmail.com
+90 212 909 60 00
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 30
Treatments
Pediatric Craniosynostosis Surgery Cohort
Pediatric patients aged 0-6 years undergoing craniosynostosis surgery will be followed intraoperatively. Pleth variability index (PVI), perfusion index (PI), standard hemodynamic variables, fluid administration, blood loss, transfusion requirements, urine output, blood gas parameters and intraoperative complications will be recorded during surgery.
Related Therapeutic Areas
Sponsors
Leads: Muzaffer GENCER
Collaborators: Başakşehir Çam & Sakura City Hospital

This content was sourced from clinicaltrials.gov