Atelectasis, Perioperative Complication, Pneumoperitoneum
Conditions
Keywords
Atelectasis, Pneumoperitoneum, Perioperative Complication
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TEST10 mmHg Pneumoperitoneum
Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 10 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.
DIAGNOSTIC_TEST14 mmHg Pneumoperitoneum
Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.
Sponsors
Engin Çetin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 and 65 years * ASA physical status I-II * Scheduled for elective laparoscopic cholecystectomy under general anesthesia * Body mass index (BMI) \<30 kg/m² * Ability to provide written informed consent
Exclusion criteria
* Chronic pulmonary disease * Recent respiratory tract infection * Thoracic deformity or previous thoracic surgery * Preoperative pulmonary pathology * Morbid obesity * Pregnancy * Emergency surgery * Conversion to open surgery * Requirement for protocol-violating pneumoperitoneum pressure modification * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Lung Ultrasound Score (LUS) Change From Baseline | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Airway Pressure (cmH₂O) | T0: Before pneumoperitoneum initiation (baseline); T1: 30 minutes after pneumoperitoneum initiation; T2: At the end of surgery before pneumoperitoneum desufflation | 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. |
| Dynamic Lung Compliance (mL/cmH₂O) Measured by Mechanical Ventilator | Baseline (before pneumoperitoneum) and 5, 15, 30, and 45 minutes after pneumoperitoneum initiation | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATOREngin Çetin
Kocaeli City Hospital
Outcome results
None listed