Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery (NCT07657598) | Clinical Trial Compass
RecruitingNot Applicable
Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery
Turkey (Türkiye)30 participantsStarted 2024-08-01
Plain-language 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.
Who can participate
Age range
6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Patients older than 6 years
* American Society of Anesthesiologists physical status IV
* Inappropriate preoperative fasting status
* History of significant cardiac, pulmonary or renal disease
* Patients operated at another institution and subsequently transferred to the study center
* Patients with peripheral circulatory impairment
* Withdrawal of consent by the parent or legal guardian
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is studying a monitoring tool called Pleth Variability Index during surgery — and not testing a new treatment — can you explain how my child's surgery itself would be different from standard craniosynostosis surgery, or would it be performed exactly the same way?
2The study is in Phase NA, which suggests it's observational or focused on evaluating a monitoring method rather than a new drug or procedure — does that mean the main purpose is to collect data on how well this tool tracks my child's blood pressure and fluid status during the operation, and is there any added risk to my child from being monitored this way?
3Craniosynostosis surgery can involve significant blood loss — how might the Pleth Variability Index monitoring being studied here potentially help the surgical team make better decisions about fluids or blood transfusions during the procedure, and is that benefit proven or still being investigated?
4Since the trial is actively recruiting, what would participation actually involve for us as a family — are there extra procedures, additional time at the hospital, or follow-up visits beyond what standard care would require?
5If we choose not to participate in this study, would my child still receive the same quality of surgical care and monitoring at your institution, and is there a standard-of-care approach you'd recommend we consider first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters
Timeframe: From induction of anesthesia until the end of surgery