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NCT Number: NCT07602543

Lung Ultrasound Evaluation of Individualized Versus Standard PEEP on Postoperative Atelectasis in Gynecological Laparoscopy

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.

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Key information

Conditions

Atelectasis Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Etlik City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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