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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lung Ultrasonography (LUS) Score
Time Frame: Preoperatively (baseline), 1 hour postoperatively, and 24 hours postoperatively.
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.
Preoperatively (baseline), 1 hour postoperatively, and 24 hours postoperatively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation Between Intraoperative Ventilation Parameters and Early Postoperative LUS Scores
Time Frame: From the start of anesthesia until 1 hour postoperatively.
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).
From the start of anesthesia until 1 hour postoperatively.
Correlation Between Intraoperative Ventilation Parameters and Postoperative Oxygenation
Time Frame: From the start of anesthesia until 1 hour postoperatively.
Evaluation of the relationship between intraoperative respiratory parameters (Ppeak, Pplat, and Compliance) and postoperative peripheral oxygen saturation (SpO₂) in the PACU.
From the start of anesthesia until 1 hour postoperatively.
Correlation Between Intraoperative Ventilation Parameters and Early Postoperative Pulmonary Complications
Time Frame: From the start of anesthesia up to 24 hours postoperatively.
Evaluation of whether intraoperative respiratory parameters (Ppeak, Pplat, and Compliance) are associated with the development of clinical pulmonary complications within the first 24 hours.
From the start of anesthesia up to 24 hours postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Etlik City Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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