Pneumoperitoneum Pressure and Lung Ultrasound Atelectasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEngin Çetin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Chronic pulmonary disease
Recent respiratory tract infection
Thoracic deformity or previous thoracic surgery
Preoperative pulmonary pathology
Trial design
Design model
Parallel
Treatments tested in this trial
10 mmHg Pneumoperitoneum
Diagnostic testLaparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 10 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.
14 mmHg Pneumoperitoneum
Diagnostic testLaparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: 10 mmHg PneumoperitoneumActive comparator 1 intervention
Group B: 14 mmHg PneumoperitoneumActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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)Secondary outcomes
1
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.
Time frame
T0: Before pneumoperitoneum initiation (baseline); T1: 30 minutes after pneumoperitoneum initiation; T2: At the end of surgery before pneumoperitoneum desufflation2
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.
Time frame
Baseline (before pneumoperitoneum) and 5, 15, 30, and 45 minutes after pneumoperitoneum initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Engin Çetin
Lead sponsor
Kocaeli City Hospital
Sponsor institution
Source ClinicalTrials.gov