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

NCT06224868 | Unknown

• 1 other identifier: KA 23/230
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cholecystitis

Keywords

laparoscopic surgery; pneumoperitoneum; optic nerve sheath diameter

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (3)

PEEP 0

ACTIVE COMPARATOR

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

Other: insufflation; Other: desufflation

PEEP 5

ACTIVE COMPARATOR

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

Other: insufflation; Other: desufflation

PEEP 10

ACTIVE COMPARATOR

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

Other: insufflation; Other: desufflation

Interventions

insufflation OTHER

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.

PEEP 0; PEEP 10; PEEP 5

desufflation OTHER

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.

PEEP 0; PEEP 10; PEEP 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged all female and male volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead

MeSH Terms

Conditions

Cholecystitis; Pneumoperitoneum

Interventions

Insufflation

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Therapeutics

Central Study Contacts

Begum N Gokdemir

CONTACT

03122036868; begokdemir@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The anesthesiologist will not tell the radiologist making ultrasonography (USG) measurements which PEEP she set on the mechanical ventilator.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Group 1: PEEP 0 Group 2: PEEP 5 Group 3: PEEP 10

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 25, 2024
• Study Start: January 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share