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临床试验/NCT06224868
NCT06224868尚未招募不适用

Comparison of the Effects of Different PEEP Values With USG on Optic Nerve Sheath Diameter (ONSD), Diaphragmatic Thickness ,and Lung Score in Laparoscopic Surgery Patients

Baskent University0 个研究点目标入组 45 人开始时间: 2024年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
主要终点
comparison of diameter of optic nerve sheath with ultrasonography (USG) for different PEEP values

研究概览

简要总结

Laparoscopic surgeries are now more popular because of the advantages such as shorter hospital stay, minimal scar. In order to perform laparoscopic surgery, pneumoperitoneum should be initiated. The optic nerve sheath is an extension of the dura mater and the subarachnoid space is continuous with the intracranial subarachnoid space. Therefore, non-invasive monitoring of the increase in intracranial pressure (ICP) can be achieved by measuring the optic nerve and sheath diameter with ultrasound. Since ONSD measurement with ultrasound is an easily applicable technique, it is useful in monitoring intracranial pressure changes based on the optic nerve diameter during intraoperative changes

详细描述

Laparoscopic surgeries are now becoming increasingly common compared to traditional laparotomies, as they have advantages such as more minimal scarring, shorter hospital stay, fewer complications, and early mobilization. In these surgeries, pneumoperitoneum provided with carbon dioxide (CO2) has many effects on the cardiovascular, pulmonary, renal, metabolic and cerebral systems. Pulmonary compliance and functional residual capacity decrease due to pnemoperitoneum, ventilation/perfusion mismatch occurs, and as a result, hypoxemia may occur. A minimum of 4-6 cm H20 positive end-expiratory pressure (PEEP) should be applied to all intubated patients under general anesthesia to reduce postoperative pulmonary complications (especially atelectasis) and prevent ventilation/perfusion mismatch and hypoxemia. The optic nerve sheath is an extension of the dura mater and the subarachnoid space is continuous with the intracranial subarachnoid space. Therefore, non-invasive monitoring of the increase in intracranial pressure (ICP) can be achieved by measuring the optic nerve and sheath diameter with ultrasound. When ICP is > 20 mm Hg, measuring the optic nerve sheath diameter (ONSD) between 5.2 and 5.9 mm has a sensitivity of 74-95% and a specificity of 74-100%. Since ONSD measurement with ultrasound is an easily applicable technique, it is useful in monitoring intracranial pressure changes based on the optic nerve diameter during intraoperative changes (trendelenburg/reverse trendelenburg position, pneumoperitoneum , PEEP in mechanical ventilation).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

盲法说明

The anesthesiologist will not tell the radiologist making ultrasonography (USG) measurements which PEEP she set on the mechanical ventilator.

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
是

入选标准

  • •18- 65 aged all female and male volunteers

排除标准

  • •acute or chronic eye diseases,
  • •uncontrolled hypertension,
  • •known lung disease,
  • •body mass index (BMI) over 35 kg/m2,
  • •devices using bulbs with known intracranial charging,
  • •who refuse to participate in care

研究组 & 干预措施

PEEP 0

Active Comparator

After the patient is intubated, PEEP 0 will be set on the mechanical ventilator.

干预措施: insufflation (Other)

PEEP 0

Active Comparator

After the patient is intubated, PEEP 0 will be set on the mechanical ventilator.

干预措施: desufflation (Other)

PEEP 5

Active Comparator

After the patient is intubated, PEEP 5 will be set on the mechanical ventilator.

干预措施: insufflation (Other)

PEEP 5

Active Comparator

After the patient is intubated, PEEP 5 will be set on the mechanical ventilator.

干预措施: desufflation (Other)

PEEP 10

Active Comparator

After the patient is intubated, PEEP 10 will be set on the mechanical ventilator.

干预措施: insufflation (Other)

PEEP 10

Active Comparator

After the patient is intubated, PEEP 10 will be set on the mechanical ventilator.

干预措施: desufflation (Other)

结局指标

主要结局

comparison of diameter of optic nerve sheath with ultrasonography (USG) for different PEEP values

时间窗: Intraoperatively

comparison of diameter of optic nerve sheath (ONSD) for different PEEP values with ultrasonography (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O)

comparison of diaphragmatic thickness with USG for different PEEP values

时间窗: Intraoperatively

comparison of diaphragmatic thickness with USG for different PEEP values (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O)

comparison of lung ultrasound scores (LUS) via USG for different PEEP values

时间窗: Intraoperatively

comparison of lung scores with USG for different PEEP values (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O). This measurement calculated by LUS assigns 0 points to A lines or \< 2 separate B lines plus regular sliding; 1 point with lines B ≥ 3 or spaced focal points plus regular sliding; 2 points with coalescing B lines, and 3 points to pulmonary consolidations with a score ranging from 0 (normal lungs) to 36 (worst case scenario)

次要结局

  • comparison of diameter of optic nerve sheath via USG with different intraabdominal pressures.(Intraoperatively)
  • comparison of diaphragmatic thickness with USG with different intraabdominal pressures.(Intraoperatively)
  • comparison of lung ultrasound scores (LUS) via USG with different intraabdominal pressures.(Intraoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Begüm Nemika Gökdemir

Research Assistant

Baskent University

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