Pneumoperitoneum Pressure and Lung Ultrasound Atelectasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 10 mmHg Pneumoperitoneum, 14 mmHg Pneumoperitoneum.
- Who it may be relevant to
- Registry conditions: Atelectasis, Perioperative Complication, Pneumoperitoneum. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Different Pneumoperitoneum Pressures on Perioperative Atelectasis Assessed by Lung Ultrasound in Laparoscopic Cholecystectomy: A Prospective Randomized Single-Blind Controlled Trial
Overview
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 test 10 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 test 14 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.
Primary outcome measures
- Total Lung Ultrasound Score (LUS) Change From Baseline [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 outcome measures (2)
- Peak Airway Pressure (cmH₂O) [Time frame: 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 [Time frame: Baseline (before pneumoperitoneum) and 5, 15, 30, and 45 minutes after pneumoperitoneum initiation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
Turkey (Türkiye) · 1 center
- University of Health Sciences Kocaeli City Hospital — İzmit
Publications
- 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 37893501
Identifiers
NCT: NCT07609615 · KSH-ANREA-EC-06