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Recruiting NCT07657598

Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery

— Observational Craniosynostosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Craniosynostosis. Basic parameters: up to 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

  • Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters [Time frame: From induction of anesthesia until the end of surgery]
Secondary outcome measures (5)
  • Association Between Perfusion Index and Intraoperative Hemodynamic Parameters [Time frame: From induction of anesthesia until the end of surgery]
  • Association of PVI and PI With Intraoperative Blood Loss and Transfusion Requirement [Time frame: From skin incision until the end of surgery]
  • Association of PVI and PI With Intraoperative Fluid Replacement [Time frame: From induction of anesthesia until the end of surgery]
  • Association of PVI and PI With Intraoperative Metabolic and Perfusion Parameters [Time frame: From induction of anesthesia until the end of surgery]
  • Intraoperative Hemodynamic Complications [Time frame: From induction of anesthesia until the end of surgery]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Basaksehir Cam and Sakura City Hospital — Istanbul

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07657598 · PVI-CRANIO-SD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗