Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters [Срок оценки: From induction of anesthesia until the end of surgery]

Вторичные конечные точки (5)

• Association Between Perfusion Index and Intraoperative Hemodynamic Parameters [Срок оценки: From induction of anesthesia until the end of surgery]
• Association of PVI and PI With Intraoperative Blood Loss and Transfusion Requirement [Срок оценки: From skin incision until the end of surgery]
• Association of PVI and PI With Intraoperative Fluid Replacement [Срок оценки: From induction of anesthesia until the end of surgery]
• Association of PVI and PI With Intraoperative Metabolic and Perfusion Parameters [Срок оценки: From induction of anesthesia until the end of surgery]
• Intraoperative Hemodynamic Complications [Срок оценки: From induction of anesthesia until the end of surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Basaksehir Cam and Sakura City Hospital — Istanbul

Публикации

• 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

Идентификаторы

NCT: NCT07657598 · PVI-CRANIO-SD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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