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

NCT07602543 | Active Not Recruiting

• 1 other identifier: AEŞH-BADEK2-2026-188
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atelectasis

Keywords

Positive End-Expiratory Pressure; Driving Pressure; Lung Ultrasound; Laparoscopy; Gynecologic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Lung Ultrasonography (LUS) Score

  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 Outcomes (3)

• Correlation Between Intraoperative Ventilation Parameters and Early Postoperative LUS Scores

  From the start of anesthesia until 1 hour postoperatively.

• Correlation Between Intraoperative Ventilation Parameters and Postoperative Oxygenation

  From the start of anesthesia until 1 hour postoperatively.

• Correlation Between Intraoperative Ventilation Parameters and Early Postoperative Pulmonary Complications

  From the start of anesthesia up to 24 hours postoperatively.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• ILKAY BARAN AKKUS, MD, Associate Professor

  Ankara Etlik City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESIDENT IN ANESTHESIOLOGY

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 22, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)