Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery (PVI-CRANIO)
13 juni 2026 bijgewerkt door: Muzaffer GENCER
Association of Pleth Variability Index Monitoring With Intraoperative Hemodynamic Control in Pediatric Craniosynostosis Surgery
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.
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
Craniosynostosis surgery in pediatric patients is associated with a high risk of intraoperative blood loss and hemodynamic instability. Because children have a relatively low circulating blood volume, early detection of intravascular volume changes is essential for maintaining adequate perfusion and preventing hypotension. Goal-directed fluid management may improve oxygen delivery and overall hemodynamic stability during major surgical procedures.
Pleth variability index (PVI) is a noninvasive dynamic parameter derived from pulse oximetry waveform analysis and reflects respiratory variations in the perfusion index (PI). PI and PVI may provide useful information regarding peripheral perfusion, volume status and fluid responsiveness during mechanical ventilation. However, data regarding the utility of these parameters in pediatric craniosynostosis surgery are limited.
In this prospective observational study, pediatric patients aged 0-6 years undergoing craniosynostosis surgery will be followed intraoperatively. PVI and PI values will be recorded at predefined time points during surgery together with standard hemodynamic and perioperative parameters. Systolic, diastolic and mean arterial pressure, heart rate, central venous pressure, oxygen saturation, body temperature, urine output, estimated blood loss, amount of fluid replacement, blood product requirement, serum lactate level, blood gas parameters and intraoperative complications will be documented. The relationship between PVI/PI measurements and intraoperative hemodynamic changes, bleeding, fluid administration and transfusion requirements will be analyzed.
Studietype
Observationeel
Inschrijving (Geschat)
30
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Muzaffer Gencer, associate professor
- Telefoonnummer: +90 212 909 60 00
- E-mail: dr.m.gencer07@gmail.com
Studie Locaties
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Basaksehir
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Istanbul, Basaksehir, Turkije (Türkiye), 34480
- Werving
- Başakşehir Çam and Sakura City Hospital
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Contact:
- Muzaffer Gencer, associate professor
- Telefoonnummer: +90 212 909 60 00
- E-mail: dr.m.gencer07@gmail.com
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
NVT
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters
Tijdsspanne: From induction of anesthesia until the end of surgery
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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.
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From induction of anesthesia until the end of surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Association Between Perfusion Index and Intraoperative Hemodynamic Parameters
Tijdsspanne: From induction of anesthesia until the end of surgery
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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.
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From induction of anesthesia until the end of surgery
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Association of PVI and PI With Intraoperative Blood Loss and Transfusion Requirement
Tijdsspanne: From skin incision until the end of surgery
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The relationship between PVI/PI measurements and estimated blood loss, intraoperative fluid replacement and blood product transfusion requirement will be analyzed.
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From skin incision until the end of surgery
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Association of PVI and PI With Intraoperative Fluid Replacement
Tijdsspanne: From induction of anesthesia until the end of surgery
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The relationship between PVI/PI values and the amount of intraoperative crystalloid, colloid and blood product administration will be evaluated.
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From induction of anesthesia until the end of surgery
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Association of PVI and PI With Intraoperative Metabolic and Perfusion Parameters
Tijdsspanne: From induction of anesthesia until the end of surgery
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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.
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From induction of anesthesia until the end of surgery
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Intraoperative Hemodynamic Complications
Tijdsspanne: From induction of anesthesia until the end of surgery
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The incidence of intraoperative hemodynamic complications, including hypotension and clinically significant hemodynamic instability requiring intervention, will be recorded.
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From induction of anesthesia until the end of surgery
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Moradi Farsani D, Mazaheri Z, Shafa A. The Effect of Tranexamic Acid and Controlled Hypotension on Perioperative Blood Loss in Craniosynostosis Surgery. Anesth Pain Med. 2023 Jan 16;13(1):e130462. doi: 10.5812/aapm-130462. eCollection 2023 Feb.
- Kearney RA, Rosales JK, Howes WJ. Craniosynostosis: an assessment of blood loss and transfusion practices. Can J Anaesth. 1989 Jul;36(4):473-7. doi: 10.1007/BF03005352.
- Demirci OL, Cikrikci Isik G, Corbacioglu SK, Cevik Y. Comparing Pleth variability index (PVI) variation induced by passive leg raising and Trendelenburg position in healthy volunteers. Am J Emerg Med. 2020 Feb;38(2):278-281. doi: 10.1016/j.ajem.2019.05.015. Epub 2019 May 7. No abstract available.
- Nayak P, Singha SK, Khetrapal M, Sharma A. A Randomised Controlled Study Comparing Pulse Pressure Variation (PPV) and Pleth Variability Index (PVI) for Goal-Directed Fluid Therapy Intraoperatively in Patients Undergoing Intracranial (Supratentorial ICSOLs) Surgeries. Rom J Anaesth Intensive Care. 2023 Apr 20;30(1):18-25. doi: 10.2478/rjaic-2023-0003. eCollection 2023 Apr.
- Broch O, Bein B, Gruenewald M, Hocker J, Schottler J, Meybohm P, Steinfath M, Renner J. Accuracy of the pleth variability index to predict fluid responsiveness depends on the perfusion index. Acta Anaesthesiol Scand. 2011 Jul;55(6):686-93. doi: 10.1111/j.1399-6576.2011.02435.x. Epub 2011 Apr 11.
- Hughes C, Thomas K, Johnson D, Das S. Anesthesia for surgery related to craniosynostosis: a review. Part 2. Paediatr Anaesth. 2013 Jan;23(1):22-7. doi: 10.1111/j.1460-9592.2012.03922.x. Epub 2012 Aug 7.
- Renner J, Broch O, Gruenewald M, Scheewe J, Francksen H, Jung O, Steinfath M, Bein B. Non-invasive prediction of fluid responsiveness in infants using pleth variability index. Anaesthesia. 2011 Jul;66(7):582-9. doi: 10.1111/j.1365-2044.2011.06715.x. Epub 2011 May 3.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 augustus 2024
Primaire voltooiing (Geschat)
1 januari 2028
Studie voltooiing (Geschat)
1 februari 2028
Studieregistratiedata
Eerst ingediend
13 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
13 juni 2026
Eerst geplaatst (Werkelijk)
18 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
13 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PVI-CRANIO-SD
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Individual participant data will not be shared due to the pediatric study population, the small sample size and the potential risk of participant re-identification despite de-identification.
Aggregate study results may be shared in scientific publications or presentations.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .