Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery
Official title: Association of Pleth Variability Index Monitoring With Intraoperative Hemodynamic Control in Pediatric Craniosynostosis Surgery
Run by Başakşehir Çam & Sakura City Hospital · NCT07657598 · Data updated 2026-11-12
This observational study will see if noninvasive PVI and PI monitoring during craniosynostosis surgery in children helps track bleeding and fluid needs.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 6 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Başakşehir Çam & Sakura City Hospital Government |
| Locations | 1 site (Istanbul, Basaksehir) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | January 1, 2028 |
| Study ends | February 1, 2028 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT07657598 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pediatric patients aged 0-6 years scheduled for craniosynostosis surgery, ASA I-III, with informed consent from a parent or legal guardian.
✕Probably not a fit
Patients with ASA IV, significant preexisting organ disease, peripheral circulatory impairment, or those who do not undergo the study protocol may not benefit from this monitoring approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study enrolls children aged 0-6 years undergoing craniosynostosis surgery to monitor pleth variability index (PVI) and perfusion index (PI) alongside standard intraoperative parameters. Researchers will collect hemodynamic data, blood loss, fluid replacement, transfusion needs, lactate, blood gases, and perioperative complications to explore associations with PVI/PI changes. The goal is to determine whether these noninvasive indices correlate with volume status and hemodynamic stability during pediatric craniosynostosis procedures. The findings could inform goal-directed fluid management to improve perfusion and reduce complications in this high-risk population.
Why it matters
Potential benefit: If successful, PVI/PI monitoring could help clinicians tailor fluid management to improve perfusion and stability during pediatric craniosynostosis surgery.
How similar studies have gone: Prior data on PVI/PI in children are limited, with some adult and perioperative studies suggesting potential utility but lacking robust pediatric craniosynostosis data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Basaksehir Cam and Sakura City Hospital
Istanbul, Basaksehir, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Muzaffer Gencer, associate professor
- Email: dr.m.gencer07@gmail.com
- Phone: +90 212 909 60 00
Similar studies
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Examining eye conditions in patients with craniosynostosis
This study looks at the eye problems that can happen in people with craniosynostosis to better understand their eye health and improve their care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.