Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery
ConditionCraniosynostosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 6
SponsorMuzaffer GENCER
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients older than 6 years
American Society of Anesthesiologists physical status IV
Inappropriate preoperative fasting status
History of significant cardiac, pulmonary or renal disease
Trial population
Pediatric patients aged 0-6 years who are scheduled to undergo craniosynostosis surgery at Başakşehir Çam and Sakura City Hospital will constitute the study population.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Pediatric Craniosynostosis Surgery Cohort
Trial outcomes
Primary outcomes
1
Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters
The primary outcome is the association between intraoperative pleth variability index (PVI) values and hemodynamic parameters, including systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate and central venous pressure, in pediatric patients undergoing craniosynostosis surgery.
Time frame
From induction of anesthesia until the end of surgerySecondary outcomes
1
Association Between Perfusion Index and Intraoperative Hemodynamic Parameters
The association between intraoperative perfusion index (PI) values and systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate, central venous pressure and oxygen saturation will be evaluated.
Time frame
From induction of anesthesia until the end of surgery2
Association of PVI and PI With Intraoperative Blood Loss and Transfusion Requirement
The relationship between PVI/PI measurements and estimated blood loss, intraoperative fluid replacement and blood product transfusion requirement will be analyzed.
Time frame
From skin incision until the end of surgery3
Association of PVI and PI With Intraoperative Fluid Replacement
The relationship between PVI/PI values and the amount of intraoperative crystalloid, colloid and blood product administration will be evaluated.
Time frame
From induction of anesthesia until the end of surgery4
Association of PVI and PI With Intraoperative Metabolic and Perfusion Parameters
The association between PVI/PI measurements and serum lactate level, blood gas pH, base excess, central venous oxygen saturation, urine output and body temperature will be assessed.
Time frame
From induction of anesthesia until the end of surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Muzaffer GENCER
Lead sponsor
Başakşehir Çam & Sakura City Hospital
Sponsor institution
Başakşehir Çam & Sakura City Hospital
Collaborator
Source ClinicalTrials.gov