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| ID | Type | Description | Link |
|---|---|---|---|
| 2024/54 | Other Identifier | Niğde Ömer Halisdemir University Faculty of Medicine |
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This prospective interventional study will evaluate the effects of applying positive end-expiratory pressure (PEEP) at 10 cmH₂O on optic nerve sheath diameter (ONSD) in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. A total of approximately 40 adult patients (ASA physical status I-II) will be included following informed consent.
ONSD will be measured using a high-frequency linear ultrasound probe at three predefined intraoperative time points: (T0) 10 minutes after initiation of mechanical ventilation, (T1) 10 minutes after pneumoperitoneum creation, and (T2) 30 minutes after pneumoperitoneum creation. Dynamic lung compliance, peak airway pressure (Ppeak), end-tidal CO₂ (EtCO₂), heart rate, mean arterial pressure, and SpO₂ will also be recorded.
The aim is to assess whether the application of PEEP influences intracranial pressure indicators, particularly ONSD, during laparoscopic procedures. The study may provide valuable insights into the neurophysiological effects of intra-abdominal pressure and mechanical ventilation strategies in surgical patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEEP Group | Experimental | This arm includes patients undergoing laparoscopic cholecystectomy under general anesthesia. All participants receive 10 cmH₂O PEEP after pneumoperitoneum creation, and optic nerve sheath diameter (ONSD) is measured intraoperatively at predefined time points. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive End-Expiratory Pressure (PEEP) | Procedure | Application of 10 cmH₂O PEEP during mechanical ventilation after pneumoperitoneum creation in patients undergoing laparoscopic cholecystectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Optic Nerve Sheath Diameter (ONSD) | ONSD will be measured via ultrasound at 3 time points during surgery. | Intraoperative; T0, T1, T2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Airway Pressure (Ppeak) | Peak airway pressure will be measured using the ventilator settings at three predefined intraoperative time points to evaluate respiratory mechanics during PEEP application. | Intraoperative measurement at T0, T1, and T2 |
| Change in Dynamic Lung Compliance |
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Inclusion Criteria:
- Adult patients (age ≥ 18 years)
American Society of Anesthesiologists (ASA) physical status I-III
Scheduled for elective laparoscopic cholecystectomy under general anesthesia
Signed informed consent
Exclusion Criteria:
Uncontrolled hypertension
Asthma or known chronic pulmonary disease
Any neurological disorders
Body mass index (BMI) > 35 kg/m²
Use of medications known to affect intracranial pressure
Refusal to participate after signing informed consent
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niğde Training and Research Hospital | Niğde | Niğde Province | 5200 | Turkey (Türkiye) |
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Dynamic lung compliance will be calculated using the formula: Tidal Volume / (Ppeak - PEEP) and measured at three intraoperative time points. |
| Intraoperative measurement at T0, T1, and T2 |
| Change in End-Tidal Carbon Dioxide (EtCO₂) | End-tidal CO₂ levels will be recorded intraoperatively to monitor changes in ventilation efficiency during surgery. | Intraoperative measurement at T0, T1, and T2 |
| Changes in Heart Rate (HR) and Mean Arterial Pressure (MAP) Time Frame | Heart rate and mean arterial pressure will be recorded at predefined time points to assess hemodynamic stability during surgery. | Intraoperative measurement at T0, T1, and T2 |
| Peripheral Oxygen Saturation (SpO₂) | Peripheral oxygen saturation will be monitored continuously and recorded at specified intraoperative time points. | Intraoperative continuous monitoring and recorded at T0, T1, and T2 |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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