Clinical trial NCT06224868: Comparison of the Effects of Different PEEP Values With USG on Optic Nerve Sheath Diameter
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cholecystitis
Keywords: laparoscopic surgery
pneumoperitoneum
optic nerve sheath diameter
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: PEEP 0 Group 2: PEEP 5 Group 3: PEEP 10
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 18- 65 aged all female and male volunteers

Exclusion Criteria:

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

Primary outcomes:
measure: comparison of diameter of optic nerve sheath with ultrasonography (USG) for different PEEP values
timeFrame: Intraoperatively
measure: comparison of diaphragmatic thickness with USG for different PEEP values
timeFrame: Intraoperatively
measure: comparison of lung ultrasound scores (LUS) via USG for different PEEP values
timeFrame: Intraoperatively
Secondary outcomes:
measure: comparison of diameter of optic nerve sheath via USG with different intraabdominal pressures.
timeFrame: Intraoperatively
measure: comparison of diaphragmatic thickness with USG with different intraabdominal pressures.
timeFrame: Intraoperatively
measure: comparison of lung ultrasound scores (LUS) via USG with different intraabdominal pressures.
timeFrame: Intraoperatively
Other outcomes:
Locations:
Study officials:
References: