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

2026年6月13日 更新者：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.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 土耳其（türkiye）
    • Basaksehir
      • Istanbul、Basaksehir、土耳其（türkiye）、34480
        • 招聘中
        • Başakşehir Çam and Sakura City Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Association Between Perfusion Index and Intraoperative Hemodynamic Parameters
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Muzaffer GENCER

合作者

Başakşehir Çam & Sakura City Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年8月1日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2026年6月13日

首先提交符合 QC 标准的

2026年6月13日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月13日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PVI-CRANIO-SD

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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