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Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery (PVI-CRANIO)

13 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

30

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Turkiet (Türkiye)
    • Basaksehir
      • Istanbul, Basaksehir, Turkiet (Türkiye), 34480
        • Rekrytering
        • Başakşehir Çam and Sakura City Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

N/A

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters
Tidsram: From induction of anesthesia until the end of surgery
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.
From induction of anesthesia until the end of surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Association Between Perfusion Index and Intraoperative Hemodynamic Parameters
Tidsram: From induction of anesthesia until the end of surgery
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.
From induction of anesthesia until the end of surgery
Association of PVI and PI With Intraoperative Blood Loss and Transfusion Requirement
Tidsram: From skin incision until the end of surgery
The relationship between PVI/PI measurements and estimated blood loss, intraoperative fluid replacement and blood product transfusion requirement will be analyzed.
From skin incision until the end of surgery
Association of PVI and PI With Intraoperative Fluid Replacement
Tidsram: From induction of anesthesia until the end of surgery
The relationship between PVI/PI values and the amount of intraoperative crystalloid, colloid and blood product administration will be evaluated.
From induction of anesthesia until the end of surgery
Association of PVI and PI With Intraoperative Metabolic and Perfusion Parameters
Tidsram: From induction of anesthesia until the end of surgery
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.
From induction of anesthesia until the end of surgery
Intraoperative Hemodynamic Complications
Tidsram: From induction of anesthesia until the end of surgery
The incidence of intraoperative hemodynamic complications, including hypotension and clinically significant hemodynamic instability requiring intervention, will be recorded.
From induction of anesthesia until the end of surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Muzaffer GENCER

Samarbetspartners

Başakşehir Çam & Sakura City Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 augusti 2024

Primärt slutförande (Beräknad)

1 januari 2028

Avslutad studie (Beräknad)

1 februari 2028

Studieregistreringsdatum

Först inskickad

13 juni 2026

Först inskickad som uppfyllde QC-kriterierna

13 juni 2026

Första postat (Faktisk)

18 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PVI-CRANIO-SD

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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