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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06224868
Enrollment
45
Registered
2024-01-25
Start date
2024-01-15
Completion date
2024-06-15
Last updated
2024-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis

Keywords

laparoscopic surgery, pneumoperitoneum, optic nerve sheath diameter

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).

Interventions

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.

OTHERdesufflation

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.

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
comparison of diameter of optic nerve sheath with ultrasonography (USG) for different PEEP valuesIntraoperativelycomparison 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 valuesIntraoperativelycomparison 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 valuesIntraoperativelycomparison 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)

Secondary

MeasureTime frameDescription
comparison of diameter of optic nerve sheath via USG with different intraabdominal pressures.Intraoperativelycomparison 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.
comparison of diaphragmatic thickness with USG with different intraabdominal pressures.Intraoperativelycomparison 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.
comparison of lung ultrasound scores (LUS) via USG with different intraabdominal pressures.Intraoperativelycomparison of lung ultrasound scores (LUS) via USG with different intraabdominal pressures. ( insufflation and desufflation)

Contacts

Primary ContactBegum N Gokdemir
begokdemir@yahoo.com03122036868

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026