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Elective laparoscopic cholecystectomy may lead to perioperative atelectasis due to pneumoperitoneum-related diaphragmatic elevation and impaired respiratory mechanics. Lung ultrasound (LUS) provides a noninvasive bedside method for evaluating perioperative aeration loss. This prospective randomized controlled study aims to compare the effects of low-pressure (10 mmHg) and standard-pressure (14 mmHg) pneumoperitoneum on perioperative atelectasis assessed by LUS in patients undergoing laparoscopic cholecystectomy under general anesthesia. Changes in LUS scores, respiratory mechanics, oxygenation, and postoperative clinical outcomes will also be evaluated.
Elective laparoscopic cholecystectomy may cause perioperative atelectasis due to pneumoperitoneum-related impairment of respiratory mechanics. Lung ultrasound (LUS) is a noninvasive bedside tool that can evaluate perioperative lung aeration loss and atelectasis.
This prospective randomized single-blind controlled trial aims to compare the effects of low-pressure (10 mmHg) and standard-pressure (14 mmHg) pneumoperitoneum on perioperative atelectasis assessed by LUS in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Patients will be randomized into two groups according to pneumoperitoneum pressure level.
LUS assessments will be performed before pneumoperitoneum, at the end of surgery before extubation, and at the postoperative first hour. The primary outcome will be the change in LUS score from baseline to the end of surgery. Secondary outcomes will include respiratory mechanics, oxygenation parameters, postoperative oxygen requirement, postoperative pain, nausea-vomiting, and recovery outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mmHg Pneumoperitoneum | Active Comparator | Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 10 mmHg. |
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| 14 mmHg Pneumoperitoneum | Active Comparator | Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 mmHg Pneumoperitoneum | Diagnostic Test | Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 10 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Lung Ultrasound Score (LUS) Change From Baseline | Perioperative lung aeration loss and atelectasis will be assessed using the Lung Ultrasound Score (LUS) during laparoscopic cholecystectomy performed under two different pneumoperitoneum pressures (10 mmHg vs 14 mmHg). Lung ultrasonography will be performed on predefined anterior and lateral chest wall regions bilaterally. Each lung region will be scored from 0 to 3 according to the degree of aeration loss, and the total LUS will range from 0 to 24. Higher scores indicate greater loss of lung aeration and more severe atelectasis. | T0: After anesthesia induction and before pneumoperitoneum initiation (baseline); T1: At the end of surgery before extubation; T2: 1 hour after arrival in the post-anesthesia care unit (PACU) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Airway Pressure (cmH₂O) | Intraoperative peak airway pressure (cmH₂O) during laparoscopic cholecystectomy will be measured using the anesthesia ventilator and compared between the low-pressure pneumoperitoneum (10 mmHg) and standard-pressure pneumoperitoneum (14 mmHg) groups. | T0: Before pneumoperitoneum initiation (baseline); T1: 30 minutes after pneumoperitoneum initiation; T2: At the end of surgery before pneumoperitoneum desufflation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Engin Çetin | Contact | 05321206004 | Doccetin52@gmail.com | |
| Engin Cetin | Contact | 05321206004 | Doccetin52@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Engin Çetin | Kocaeli City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Kocaeli City Hospital | Recruiting | İzmit | Kocaeli | 41200 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37893501 | Background | Turan Civraz AZ, Saracoglu A, Saracoglu KT. Evaluation of the Effect of Pressure-Controlled Ventilation-Volume Guaranteed Mode vs. Volume-Controlled Ventilation Mode on Atelectasis in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Clinical Trial. Medicina (Kaunas). 2023 Oct 7;59(10):1783. doi: 10.3390/medicina59101783. |
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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Parallel Assignment
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| 14 mmHg Pneumoperitoneum | Diagnostic Test | Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed. |
|
| Dynamic Lung Compliance (mL/cmH₂O) Measured by Mechanical Ventilator | Intraoperative dynamic lung compliance (mL/cmH₂O), measured using the anesthesia ventilator, will be compared between low-pressure pneumoperitoneum (10 mmHg) and standard-pressure pneumoperitoneum (14 mmHg) groups during laparoscopic cholecystectomy. | Baseline (before pneumoperitoneum) and 5, 15, 30, and 45 minutes after pneumoperitoneum initiation |