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临床试验/NCT07085949
NCT07085949已完成不适用

Evaluation of the Effect of Different Positive End-Expiratory Pressure (PEEP) Levels on Optic Nerve Sheath Diameter in Patients Undergoing Vertebral Surgery; Prospective Observational Study

Izmir City Hospital1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年7月30日最近更新:
适应症
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
105
试验地点
1
主要终点
Optic nerve sheath diameter measurement after extubation

研究概览

简要总结

The goal of this prospective observational study is to evaluate the effects of different PEEP values on the optic nerve sheath diameter (ONSD), a noninvasive indicator of intracranial pressure (ICP), in patients undergoing vertebral surgery. The main question it aims to answer is how mechanical ventilation setting of 5 and 10 cmH2O PEEP effect optic nerve sheath diameter after surgery at extubation.

详细描述

During general anesthesia, endotracheal intubation can cause varying degrees of alveolar collapse, particularly in the lower lung regions, in 15-20% of cases. Postoperative atelectasis and pulmonary infections are responsible for both prolonged hospital stays and increased mortality and morbidity. Positive end-expiratory pressure (PEEP) combined with low tidal volume, defined as lung-protective ventilation strategies, is used in anesthesia practice because it prevents pulmonary barotrauma, improves pulmonary function, and reduces postoperative pulmonary complications. PEEP can prevent atelectasis and reduce the risk of ventilator-associated lung injury. PEEP at 10 cmH2O or less can be used without causing a significant increase in intracranial pressure or a significant decrease in cerebral perfusion pressure.

For years, low PEEP was used in neurosurgery and neurosurgical intensive care patients, considering that PEEP could increase ICP. However, recent studies in normovolemic patients without hypotension have shown that even with increased PEEP, no clinically significant increase in ICP was observed.

The optic nerve is anatomically an extension of the central nervous system. Cerebrospinal fluid (CSF) circulates within this extension, which is surrounded by dura mater. Therefore, noninvasive ultrasonographic measurement of optic nerve sheath diameter (ONSD) has been shown to be effective in detecting increased intracranial pressure (ICP) due to the reflection of changes in subarachnoid space pressure and CSF on the optic nerve sheath. An optic nerve sheath diameter greater than 6 mm is a noninvasive indicator of increased intracranial pressure.

The effect of positive end-expiratory pressure (PEEP) on optic nerve sheath diameter in patients undergoing vertebral surgery will be evaluated.

Optic nerve sheath diameter measurements will be taken twice with ultrasound, once before surgery in the preoperative waiting room and once after surgery in the postoperative recovery unit.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 18-65 years
  • •ASA I, II, III
  • •Patients undergoing elective vertebral surgery in the prone position

排除标准

  • •Patients were defined as having a hemoglobin concentration below 9 g/dL
  • •Congestive heart failure
  • •Uncontrolled hypertension
  • •Severe COPD
  • •Pulmonary edema
  • •Cerebrovascular disease
  • •Those who have had carotid stenosis or surgery
  • •Hemodynamic instability
  • •Pregnant women
  • •Those who did not wish to participate in the study.

研究组 & 干预措施

PEEP 5

5 cmH2O PEEP will be administered during mechanical ventilation

干预措施: 5 cmH2O PEEP (Other)

PEEP 10

10 cmH2O PEEP will be administered during mechanical ventilation

干预措施: 10 cmH2O PEEP (Other)

结局指标

主要结局

Optic nerve sheath diameter measurement after extubation

时间窗: just after extubation

optic nerve sheath diameter will be measured at the end of the surgery after extubation

次要结局

  • systolicpressure8(up to 1 hour after prone position)
  • systolicpressure9(up to 2 hour after prone position)
  • systolicpressure10(up to 3 hour after prone position)
  • peripheral oxygen saturation (SpO₂)0(pre-ınduction)
  • peripheral oxygen saturation (SpO₂)1(up to 5 minutes after anesthesia induction)
  • peripheral oxygen saturation (SpO₂)2(up to 10 minutes after anesthesia induction)
  • peripheral oxygen saturation (SpO₂)3(up to 15 minutes after anesthesia induction)
  • peripheral oxygen saturation (SpO₂)4(up to 5 minutes after prone position)
  • peripheral oxygen saturation (SpO₂)5(up to 10 minutes after prone position)
  • peripheral oxygen saturation (SpO₂)6(up to 15 minutes after prone position)
  • peripheral oxygen saturation (SpO₂)7(up to 30 minutes after prone position)
  • peripheral oxygen saturation (SpO₂)8(up to 1 hour after prone position)
  • peripheral oxygen saturation (SpO₂)9(up to 2 hour after prone position)
  • peripheral oxygen saturation (SpO₂)10(up to 3 hour after prone position)
  • diastolicpressures0(pre induction)
  • diastolicpressures8(up to 1 hour after prone position)
  • diastolicpressures9(up to 2 hour after prone position)
  • diastolicpressures10(up to 3 hour after prone position)
  • systolicpressures0(pre-induction)
  • systolicpressure1(up to 5 minutes after anesthesia)
  • systolicpressure2(up to 10 minutes after anesthesia)
  • systolicpressure3(up to 15 minutes after anesthesia)
  • systolicpressure4(up to 5 minutes after prone position)
  • systolicpressure5(up to 10 minutes after prone position)
  • systolicpressure6(up to 15 minutes after prone position)
  • systolicpressure7(up to 30 minutes after prone position)
  • heart rate0(pre-induction)
  • heartrate2(up to 10 minutes after anesthesia induction)
  • mean arterial pressures0(pre induction)
  • mean arterial pressures1(up to 5 minutes after anesthesia)
  • mean arterial pressures2(up to 10 minutes after anesthesia induction)
  • mean arterial pressures3(up to 15 minutes after anesthesia induction)
  • mean arterial pressures4(up to 5 minutes after prone position)
  • mean arterial pressures5(up to 10 minutes after prone position)
  • mean arterial pressures6(up to 15 minutes after prone position)
  • meanarterialpressures7(up to 30 minutes after prone position)
  • heartrate1(up to 5 minutes after anesthesia induction)
  • heartrate9(up to 2 hour after prone position)
  • meanarterialpressures10(3 hour after prone position)
  • diastolicpressures1(up to 5 minutes after anesthesia induction)
  • diastolicpressures2(up to 10 minutes after anesthesia indüction)
  • diastolicpressures3(up to 15 minutes after anesthesia induction)
  • diastolicpressures4(up to 5 minutes after prone position)
  • diastolicpressures5(up to 10 minutes after prone position)
  • diastolicpressures6(up to 15 minutes after prone position)
  • diastolicpressures7(up to 30 minutes after prone position)
  • heartrate3(up to 15 minutes after anesthesia induction)
  • heartrate5(up to 10 minutes after prone position)
  • heartrate10(up to 3 hour after prone position)
  • heartrate4(up to 5 minutes after prone position)
  • heartrate8(up to 1 hour after prone position)
  • heartrate6(up to 15 minutes after prone position)
  • heartrate7(up to 30 minutes after prone position)
  • meanarterialpressures8(up to 1 hour after prone position)
  • meanarterialpressures9(2 hour after prone position)

研究者

发起方
Izmir City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Karaşah Yalçın

doctor of medicine

Izmir City Hospital

研究点 (1)

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