- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07602543
Lung Ultrasound Evaluation of Individualized Versus Standard PEEP on Postoperative Atelectasis in Gynecological Laparoscopy
May 16, 2026 updated by: Enes Özüdoğru, Ankara Etlik City Hospital
Evaluation of the Effect of Driving Pressure-Guided Individualized PEEP Titration Versus Standard PEEP on Early and Late Postoperative Atelectasis Development Using Lung Ultrasonography in Gynecological Laparoscopic Surgeries
The purpose of this study is to compare two different airway pressure (PEEP) strategies during gynecological laparoscopic surgery to see which one better prevents lung collapse (atelectasis).
We will compare a 'standard' fixed pressure with a 'personalized' pressure adjusted according to the patient's own lung mechanics (driving pressure).
We will use lung ultrasound to check the lungs before surgery, 1 hour after surgery, and 24 hours after surgery to evaluate the results.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
In this prospective observational study, we investigate the impact of PEEP strategies on lung collapse (atelectasis) in patients undergoing gynecological laparoscopy.
The Standard Group receives a routine clinical application of 5 cmH2O PEEP.
The Individualized Group undergoes a PEEP titration protocol where PEEP starts at 20 cmH2O and is adjusted to reach the optimal level based on the lowest driving pressure.
To measure the results, a 12-zone Lung Ultrasonography (LUS) scoring system (0-3 points per zone) is utilized.
Evaluations are conducted preoperatively (baseline), 1 hour postoperatively (early phase), and 24 hours postoperatively (late phase) to track the development and resolution of atelectasis.
Study Type
Observational
Enrollment (Estimated)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey (Türkiye)
- Etlik City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population consists of adult female patients (aged 18 to 65 years) with an American Society of Anesthesiologists (ASA) physical status of I, II, or III, who are scheduled for elective gynecological laparoscopic surgeries (e.g., hysterectomy, myomectomy, sacrocolpopexy) under general anesthesia with endotracheal intubation at Ankara Etlik City Hospital.
Description
Inclusion Criteria:
- Female patients aged between 18 and 65 years.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Scheduled for elective laparoscopic gynecological surgery (e.g., hysterectomy, myomectomy, sacrocolpopexy).
- Planned to undergo general anesthesia with endotracheal intubation.
- Expected surgery duration of 2 hours or more.
- Body Mass Index (BMI) ≤ 35 kg/m².
Exclusion Criteria:
- History of moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), clinically significant interstitial lung disease, or severe restrictive lung disease.
- New York Heart Association (NYHA) class III-IV heart failure, Ejection Fraction (EF) < 35%, or severe valvular disease.
- Advanced arrhythmia or hemodynamic instability (requiring high-dose vasopressor support).
- History of respiratory failure requiring mechanical ventilation within the past 4 weeks.
- Clinically or radiologically confirmed lower respiratory tract infection (e.g., pneumonia) within the past 1 month.
- Presence of thoracic deformity, large surgical dressings, severe subcutaneous emphysema, or any condition that hinders lung ultrasound evaluation.
- Pre-existing significant atelectasis or lung consolidation (defined as a score of 3 for consolidation or ≥2 zones with a score of ≥2 on preoperative LUS).
- Expected inability to perform the 24-hour postoperative ultrasound measurement (e.g., due to early discharge).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Grup 1: Standard PEEP Group
Patients undergoing gynecological laparoscopic surgery who are observed receiving a routine, fixed Positive End-Expiratory Pressure (PEEP) of 5 cmH2O during the intraoperative period.
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Grup 2: Individualized PEEP Group
Following an initial lung recruitment maneuver, patients undergo individualized PEEP titration.
PEEP is initially set to 20 cmH2O and then sequentially decreased in steps of 2 cmH2O to identify the optimal level associated with the lowest driving pressure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lung Ultrasonography (LUS) Score
Time Frame: Preoperatively (baseline), 1 hour postoperatively, and 24 hours postoperatively.
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Atelectasis severity is assessed using a 12-zone Lung Ultrasonography (LUS) scoring system.
Each zone is scored from 0 to 3 (0=normal aeration, 3=consolidation).
The total score ranges from 0 to 36.
Higher scores indicate worse lung aeration and more severe atelectasis.
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Preoperatively (baseline), 1 hour postoperatively, and 24 hours postoperatively.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation Between Intraoperative Ventilation Parameters and Early Postoperative LUS Scores
Time Frame: From the start of anesthesia until 1 hour postoperatively.
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Evaluation of the relationship between intraoperative respiratory parameters (Peak Airway Pressure [Ppeak], Plateau Pressure [Pplat], and Compliance) and early postoperative lung aeration assessed by Lung Ultrasonography (LUS) in the Post-Anesthesia Care Unit (PACU).
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From the start of anesthesia until 1 hour postoperatively.
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Correlation Between Intraoperative Ventilation Parameters and Postoperative Oxygenation
Time Frame: From the start of anesthesia until 1 hour postoperatively.
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Evaluation of the relationship between intraoperative respiratory parameters (Ppeak, Pplat, and Compliance) and postoperative peripheral oxygen saturation (SpO₂) in the PACU.
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From the start of anesthesia until 1 hour postoperatively.
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Correlation Between Intraoperative Ventilation Parameters and Early Postoperative Pulmonary Complications
Time Frame: From the start of anesthesia up to 24 hours postoperatively.
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Evaluation of whether intraoperative respiratory parameters (Ppeak, Pplat, and Compliance) are associated with the development of clinical pulmonary complications within the first 24 hours.
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From the start of anesthesia up to 24 hours postoperatively.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ILKAY BARAN AKKUS, MD, Associate Professor, Ankara Etlik City Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 18, 2026
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
May 16, 2026
First Submitted That Met QC Criteria
May 16, 2026
First Posted (Actual)
May 22, 2026
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 16, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-BADEK2-2026-188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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