AtelectasisNCT07602543
Lung Ultrasound Evaluation of Individualized Versus Standard PEEP on Postoperative Atelectasis in Gynecological Laparoscopy
An observational study of Atelectasis, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Atelectasis
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Atelectasis
- Keywords
- Positive End-Expiratory Pressure, Driving Pressure, Lung Ultrasound, Laparoscopy, Gynecologic Surgical Procedures
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperatively (baseline), 1 hour postoperatively, and 24 hours postoperatively.
Secondary outcomes (3)
Correlation Between Intraoperative Ventilation Parameters and Early Postoperative LUS Scores
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).
Measured: From the start of anesthesia until 1 hour postoperatively.
Correlation Between Intraoperative Ventilation Parameters and Postoperative Oxygenation
Evaluation of the relationship between intraoperative respiratory parameters (Ppeak, Pplat, and Compliance) and postoperative peripheral oxygen saturation (SpO₂) in the PACU.
Measured: From the start of anesthesia until 1 hour postoperatively.
Correlation Between Intraoperative Ventilation Parameters and Early Postoperative Pulmonary Complications
Evaluation of whether intraoperative respiratory parameters (Ppeak, Pplat, and Compliance) are associated with the development of clinical pulmonary complications within the first 24 hours.
Measured: From the start of anesthesia up to 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start18 Feb 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Enes Özüdoğru, Ankara Etlik City Hospital
- Investigators
- ILKAY BARAN AKKUS, MD, Associate Professor, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602543
- Sponsor's protocol ID
- AEŞH-BADEK2-2026-188
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07602543
- Acronym / sponsor ID
- AEŞH-BADEK2-2026-188
- Conditions
- Atelectasis
- Keywords
- Positive End-Expiratory Pressure, Driving Pressure, Lung Ultrasound, Laparoscopy, Gynecologic Surgical Procedures
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Correlation Between Intraoperative Ventilation Parameters and Early Postoperative LUS Scores
Time frame: 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.
Correlation Between Intraoperative Ventilation Parameters and Early Postoperative Pulmonary Complications
Time frame: From the start of anesthesia up to 24 hours postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ILKAY BARAN AKKUS, MD, Associate Professor study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atelectasis, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Ultrasonography (LUS) Score (time frame: Preoperatively (baseline), 1 hour postoperatively, and 24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.