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NCT Number: NCT07657598

Pleth Variability Index Monitoring 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.

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Key information

Conditions

Craniosynostosis Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Dysostoses Musculoskeletal Abnormalities Musculoskeletal Diseases Synostosis

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Basaksehir Cam and Sakura City Hospital

Istanbul, Basaksehir, 34480, Turkey (Türkiye)

Location status: Recruiting

Location contact

Muzaffer Gencer, associate professor

CONTACT

[email protected]

+90 212 909 60 00

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters

    Time frame: 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.

Secondary outcomes

  1. Association Between Perfusion Index and Intraoperative Hemodynamic Parameters

    Time frame: 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.

  2. Association of PVI and PI With Intraoperative Blood Loss and Transfusion Requirement

    Time frame: 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.

  3. Association of PVI and PI With Intraoperative Fluid Replacement

    Time frame: 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.

  4. Association of PVI and PI With Intraoperative Metabolic and Perfusion Parameters

    Time frame: 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.

  5. Intraoperative Hemodynamic Complications

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muzaffer Gencer, associate professor

CONTACT

[email protected]

+90 212 909 60 00

Sponsors and collaborators

Lead sponsor

Muzaffer GENCER

Other Gov

Collaborators

  • Başakşehir Çam & Sakura City Hospital

Registry information

Official study title

Association of Pleth Variability Index Monitoring With Intraoperative Hemodynamic Control in Pediatric Craniosynostosis Surgery

Acronym: PVI-CRANIO

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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