Comparing Low and Standard Pneumoperitoneum Pressures on Lung Health During Laparoscopic Gallbladder Surgery Using Ultrasound
Led by Engin Çetin · Updated on 2026-06-23
112
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying how different pressures of pneumoperitoneum affect lung function during elective laparoscopic cholecystectomy, a surgery to remove the gallbladder. This trial compares low-pressure 10 mmHg and standard-pressure 14 mmHg pneumoperitoneum to understand their effects on perioperative atelectasis, which is a partial collapse of the lungs that can occur during surgery. Lung ultrasound LUS, a noninvasive bedside tool, is used to assess lung aeration loss caused by pneumoperitoneum during general anesthesia.
Participants will be randomly assigned to one of two groups. One group will undergo surgery with pneumoperitoneum pressure maintained at 10 mmHg, and the other at 14 mmHg. Standard anesthesia and surgical protocols are followed for both groups. Lung ultrasound assessments will be performed at three time points after anesthesia induction before pneumoperitoneum starts, at the end of surgery before breathing tube removal, and one hour after arriving in the recovery unit.
During the study, participants will have their lung ultrasound scores measured to detect changes in lung aeration. Additional assessments include respiratory mechanics like airway pressure and lung compliance, oxygen levels, postoperative oxygen needs, pain, nausea, and recovery outcomes. These evaluations help researchers understand how the different pressures impact lung function and overall recovery. The study is expected to last from June 2026 to September 2026 with follow-up during the immediate postoperative period.
CONDITIONS
Brief Title
Pneumoperitoneum Pressure and Lung Ultrasound Atelectasis
Research Team
E
Engin Çetin
E
Engin Cetin
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Scheduled for elective laparoscopic cholecystectomy under general anesthesia
Body mass index (BMI) <30 kg/m²
Ability to provide written informed consent
You will not qualify if you...
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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single surgery day
Participants undergo laparoscopic gallbladder surgery with pneumoperitoneum pressure maintained at either 10 mmHg or 14 mmHg as assigned. Standard anesthesia and surgical protocols are followed.
1 surgery visit and postoperative assessments
Postoperative Monitoring
Duration - Up to 1 hour after surgery
Lung ultrasound scans and respiratory assessments are performed before pneumoperitoneum, at surgery end, and one hour after surgery. Postoperative pain, oxygen use, nausea, and recovery outcomes are also monitored.
3 assessment time points during and after surgery
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
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.
Ayse Zeynep Turan Civraz, Ayten Saracoglu, Kemal Tolga Saracoglu