Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery

NCT07657598 | Recruiting

• 1 other identifier: PVI-CRANIO-SD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Craniosynostosis

Keywords

Pleth Variability Index; Perfusion Index; Craniosynostosis Surgery; Pediatric Anesthesia; Hemodynamic Monitoring; Intraoperative Hemodynamics; Fluid Management

Outcome Measures

Primary Outcomes (1)

• Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters

  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

Secondary Outcomes (5)

• Association Between Perfusion Index and Intraoperative Hemodynamic Parameters

  From induction of anesthesia until the end of surgery

• Association of PVI and PI With Intraoperative Blood Loss and Transfusion Requirement

  From skin incision until the end of surgery

• Association of PVI and PI With Intraoperative Fluid Replacement

  From induction of anesthesia until the end of surgery

• Association of PVI and PI With Intraoperative Metabolic and Perfusion Parameters

  From induction of anesthesia until the end of surgery

• Intraoperative Hemodynamic Complications

  From induction of anesthesia until the end of surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muzaffer GENCER: lead
• Başakşehir Çam & Sakura City Hospital: collaborator

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Basaksehir, 34480, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• 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.

  PMID: 37489171 BACKGROUND

• 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.

  PMID: 2758548 BACKGROUND

• 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.

  PMID: 31109779 BACKGROUND

• 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.

  PMID: 37547491 BACKGROUND

• 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.

  PMID: 21480831 BACKGROUND

• 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.

  PMID: 22882624 BACKGROUND

• 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.

  PMID: 21539529 BACKGROUND

MeSH Terms

Conditions

Craniosynostoses

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Muzaffer Gencer, associate professor

CONTACT

+90 212 909 60 00; dr.m.gencer07@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: August 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)