Comparison of the Effects of Different PEEP Values With USG on Optic Nerve Sheath Diameter

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cholecystitis
• Intervention / Treatment: Other: insufflation; Other: desufflation

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).

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Begum N Gokdemir; Phone Number: 03122036868; Email: begokdemir@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PEEP 0; After the patient is intubated, PEEP 0 will be set on the mechanical ventilator.	Other: insufflation; Laparoscopic surgery begins with intraabdominal placement of the insufflation needle or trochar, followed by carbon dioxide (CO2) insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg (Normal values are 5-7 mmHg) it is aimed to monitor optic sheat nerve diameter and lung ultrasound score changes with different intraabdominal pressures.; Other: desufflation; Laparoscopic surgery begins with intraabdominal placement of the insufflation needle or trochar, followed by carbon dioxide (CO2) insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg. When the surgery is completed, the trochars are removed and intra-abdominal pressure is returned to normal which is 5-7 mmHg.
Active Comparator: PEEP 5; After the patient is intubated, PEEP 5 will be set on the mechanical ventilator.	Other: insufflation; Laparoscopic surgery begins with intraabdominal placement of the insufflation needle or trochar, followed by carbon dioxide (CO2) insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg (Normal values are 5-7 mmHg) it is aimed to monitor optic sheat nerve diameter and lung ultrasound score changes with different intraabdominal pressures.; Other: desufflation; Laparoscopic surgery begins with intraabdominal placement of the insufflation needle or trochar, followed by carbon dioxide (CO2) insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg. When the surgery is completed, the trochars are removed and intra-abdominal pressure is returned to normal which is 5-7 mmHg.
Active Comparator: PEEP 10; After the patient is intubated, PEEP 10 will be set on the mechanical ventilator.	Other: insufflation; Laparoscopic surgery begins with intraabdominal placement of the insufflation needle or trochar, followed by carbon dioxide (CO2) insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg (Normal values are 5-7 mmHg) it is aimed to monitor optic sheat nerve diameter and lung ultrasound score changes with different intraabdominal pressures.; Other: desufflation; Laparoscopic surgery begins with intraabdominal placement of the insufflation needle or trochar, followed by carbon dioxide (CO2) insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg. When the surgery is completed, the trochars are removed and intra-abdominal pressure is returned to normal which is 5-7 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of diameter of optic nerve sheath with ultrasonography (USG) for different PEEP values	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)	Intraoperatively
comparison of diaphragmatic thickness with USG for different PEEP values	comparison of diaphragmatic thickness with USG for different PEEP values (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O)	Intraoperatively
comparison of lung ultrasound scores (LUS) via USG for different PEEP values	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)	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of diameter of optic nerve sheath via USG with different intraabdominal pressures.	comparison of diameter of optic nerve sheath via USG with different intraabdominal pressures. ( insufflation and desufflation) Laparoscopic surgery involves insufflation of a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum. Normal intraabdominal pressure is 5-7 mmHg. Pneumoperitoneum is achieved by insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg.	Intraoperatively
comparison of diaphragmatic thickness with USG with different intraabdominal pressures.	comparison of diaphragmatic thickness with USG in different intraabdominal pressures ( insufflation and desufflation) Laparoscopic surgery involves insufflation of a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum.	Intraoperatively
comparison of lung ultrasound scores (LUS) via USG with different intraabdominal pressures.	comparison of lung ultrasound scores (LUS) via USG with different intraabdominal pressures. ( insufflation and desufflation)	Intraoperatively

Collaborators and Investigators

• Sponsor: Baskent University

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Estimated): January 25, 2024

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopic surgery; pneumoperitoneum; optic nerve sheath diameter
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis
• Other Study ID Numbers: KA 23/230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No