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临床试验/NCT06624891
NCT06624891已完成不适用

Evaluation of Perioperative Fluid Responsiveness in Neurosurgery: Interest of the Pleth Variability Index

National Institute of Neurology, Tunisia1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Value of PVI in fluid responsiveness in neurosurgery

研究概览

简要总结

This clinical trial aims to study the interest of the Pleth Variability Index (PVI) to evaluate perioperative fluid responsiveness in neurosurgery in adults.

The main question it aims to answer is:

• Does the Pleth variability index predict fluid responsiveness in neurosurgery? Researchers will compare the Pleth variability index to dela PP to see if it predicts fluid responsiveness in neurosurgery.

Once participants give their consent, they will be randomly assigned to one of two groups. In one group, fluid responsiveness will be monitored using the Pleth Variability Index, while in the other group, it will be monitored using delta PP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients proposed for intracranial surgery
  • Must be aged 18 and over
  • Must be classified as ASA I, ASA II, and ASA III according to the American Society of Anesthesiologists classification

排除标准

  • Non-consenting patients
  • Patients classified ASA IV or higher
  • Cardiac arrhythmia
  • Heart disease with left ventricular ejection fraction less than 45%
  • Obesity with a BMI greater than 40 Kg/m
  • Peripheral vascular disease
  • Severe lung disease
  • End-stage renal disease
  • Intraoperative cardiac arrhythmia
  • The occurrence of cardiac arrest
  • The occurrence of hemorrhagic shock
  • Intraoperative use of low tidal volumes or high respiratory rates.

结局指标

主要结局

Value of PVI in fluid responsiveness in neurosurgery

时间窗: chanfe of PVI value from baseline to a value more than 14% and untill the end of surgery

Investigate the value of the plethysmographic variability index (PVI) in assessing the response to perioperative vascular filling in neurosurgery.

次要结局

  • Amount of fluids administered intraoperatively(during the surgery)
  • Renal, metabolic and hydroelectrolytic repercussions.(up to the first 24 hours postoperatively)
  • Length of postoperative stay(up to hospital discharge, an average of 4 days)
  • Incidence of post-operative complications(up to hospital discharge, an average of 4 days)

研究者

发起方
National Institute of Neurology, Tunisia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hammami Rabeb

university hospital assistant

National Institute of Neurology, Tunisia

研究点 (1)

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