Pneumoperitoneum Pressure and Lung Ultrasound Atelectasis
Effects of Different Pneumoperitoneum Pressures on Perioperative Atelectasis Assessed by Lung Ultrasound in Laparoscopic Cholecystectomy: A Prospective Randomized Single-Blind Controlled Trial
1 other identifier
interventional
112
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2026
CompletedFirst Posted
Study publicly available on registry
May 27, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
May 28, 2026
May 1, 2026
3 months
May 17, 2026
May 26, 2026
Conditions
Keywords
Outcome Measures
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.
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 (2)
Peak Airway Pressure (cmH₂O)
T0: Before pneumoperitoneum initiation (baseline); T1: 30 minutes after pneumoperitoneum initiation; T2: At the end of surgery before pneumoperitoneum desufflation
Dynamic Lung Compliance (mL/cmH₂O) Measured by Mechanical Ventilator
Baseline (before pneumoperitoneum) and 5, 15, 30, and 45 minutes after pneumoperitoneum initiation
Study Arms (2)
10 mmHg Pneumoperitoneum
ACTIVE COMPARATORPatients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 10 mmHg.
14 mmHg Pneumoperitoneum
ACTIVE COMPARATORPatients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg.
Interventions
Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 10 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.
Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Engin Çetinlead
Study Sites (1)
University of Health Sciences Kocaeli City Hospital
İzmit, Kocaeli, 41200, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 37893501BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Engin Çetin
Kocaeli City Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 17, 2026
First Posted
May 27, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
May 28, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share