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临床试验/NCT07370779
NCT07370779已完成不适用

The Effect Of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter In Pediatric Patients Undergoing Craniotomy in Supine Position

Dr. Lutfi Kirdar Kartal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
optic nerve sheath diameter

研究概览

简要总结

This study evaluated the effect of positive end-expiratory pressure (PEEP) on optic nerve sheath diameter (ONSD), an indicator of intracranial pressure, in pediatric patients undergoing craniotomy in the supine position. The findings indicated that the application of PEEP did not result in a significant difference in ONSD. Although a significant decrease in systolic and diastolic blood pressure was observed with the use of PEEP, these values remained within normal ranges and did not indicate adverse hemodynamic effects. The results suggest that the use of a PEEP level of 4 cmH2O in pediatric patients with intracranial masses is safe and may be applied during the perioperative period.

研究设计

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

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients aged 6 months to 18 years
  • American Society of Anesthesiologists (ASA) physical status III
  • Scheduled for elective craniotomy in the supine position
  • Presence of an extra-axial intracranial mass
  • Written informed consent obtained from parents or legal guardians

排除标准

  • Open fontanelles
  • Orbital pathology
  • Severe increases in intracranial pressure associated with nausea, vomiting, visual disturbances, or seizures
  • Radiologic or clinical signs of brain herniation
  • Hydrocephalus
  • Cerebral infection
  • Congenital syndromes
  • History of surgery involving the optic nerve
  • Use of inotropic therapy
  • Hemodynamic instability
  • Surgical complications during the operation or procedures lasting longer than 8 hours
  • Postoperative intubation requiring intensive care unit follow-up
  • Tumors invading the optic nerve
  • Inability to obtain written informed consent from parents or legal guardians

研究组 & 干预措施

Study Group

Active Comparator

PEEP 4 group

干预措施: General Anesthesia (Drug)

Study Group

Active Comparator

PEEP 4 group

干预措施: Anesthetic Agents (Drug)

Study Group

Active Comparator

PEEP 4 group

干预措施: mechanical ventilation (MV) (Device)

Control Group

Active Comparator

PEEP 0 Group

干预措施: General Anesthesia (Drug)

Control Group

Active Comparator

PEEP 0 Group

干预措施: Anesthetic Agents (Drug)

Control Group

Active Comparator

PEEP 0 Group

干预措施: mechanical ventilation (MV) (Device)

结局指标

主要结局

optic nerve sheath diameter

时间窗: Four times in during the operation by using ultrasonography. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation

次要结局

  • Heart Rate(Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation)
  • systolic blood pressure(Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation)
  • diastolic blood pressure(Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation)
  • Peripheral oxygen saturation(Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation)

研究者

发起方
Dr. Lutfi Kirdar Kartal Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eren Karahan

Md

Dr. Lutfi Kirdar Kartal Training and Research Hospital

研究点 (1)

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