AtelectasisNCT07609615
Pneumoperitoneum Pressure and Lung Ultrasound Atelectasis
A study testing 10 mmHg Pneumoperitoneum and 14 mmHg Pneumoperitoneum in people with Atelectasis and Perioperative Complication, run by Engin Çetin at 1 site in Turkey (Türkiye).
Trial summary
Elective laparoscopic cholecystectomy may lead to perioperative atelectasis due to pneumoperitoneum-related diaphragmatic elevation and impaired respiratory mechanics. Lung ultrasound (LUS) provides a noninvasive bedside method for evaluating perioperative aeration loss. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atelectasis, Perioperative Complication, Pneumoperitoneum
- What is being tested?
- 10 mmHg Pneumoperitoneum and 14 mmHg Pneumoperitoneum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years
- ASA physical status I-II
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Body mass index (BMI) <30 kg/m²
- Ability to provide written informed consent
Who cannot join
- Chronic pulmonary disease
- Recent respiratory tract infection
- Thoracic deformity or previous thoracic surgery
- Preoperative pulmonary pathology
- Morbid obesity
- Pregnancy
Show all 10Show fewer
- Emergency surgery
- Conversion to open surgery
- Requirement for protocol-violating pneumoperitoneum pressure modification
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Kocaeli City Hospital
İzmit, Kocaeli, 41200
About this study
Official title: Effects of Different Pneumoperitoneum Pressures on Perioperative Atelectasis Assessed by Lung Ultrasound in Laparoscopic Cholecystectomy: A Prospective Randomized Single-Blind Controlled Trial
Elective laparoscopic cholecystectomy may lead to perioperative atelectasis due to pneumoperitoneum-related diaphragmatic elevation and impaired respiratory mechanics. Lung ultrasound (LUS) provides a noninvasive bedside method for evaluating perioperative aeration loss. This prospective randomized controlled study aims to compare the effects of low-pressure (10 mmHg) and standard-pressure (14 mmHg) pneumoperitoneum on perioperative atelectasis assessed by LUS in patients undergoing laparoscopic cholecystectomy under general anesthesia. Changes in LUS scores, respiratory mechanics, oxygenation, and postoperative clinical outcomes will also be evaluated.
Read the detailed description
Elective laparoscopic cholecystectomy may cause perioperative atelectasis due to pneumoperitoneum-related impairment of respiratory mechanics. Lung ultrasound (LUS) is a noninvasive bedside tool that can evaluate perioperative lung aeration loss and atelectasis.
This prospective randomized single-blind controlled trial aims to compare the effects of low-pressure (10 mmHg) and standard-pressure (14 mmHg) pneumoperitoneum on perioperative atelectasis assessed by LUS in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Patients will be randomized into two groups according to pneumoperitoneum pressure level.
LUS assessments will be performed before pneumoperitoneum, at the end of surgery before extubation, and at the postoperative first hour. The primary outcome will be the change in LUS score from baseline to the end of surgery. Secondary outcomes will include respiratory mechanics, oxygenation parameters, postoperative oxygen requirement, postoperative pain, nausea-vomiting, and recovery outcomes.
- Conditions
- Atelectasis, Perioperative Complication, Pneumoperitoneum
- Being tested
- 10 mmHg Pneumoperitoneum, 14 mmHg Pneumoperitoneum
- Keywords
- Atelectasis, Pneumoperitoneum, Perioperative Complication
- Medical subject headings
- Pulmonary Atelectasis, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mmHg PneumoperitoneumDiagnostic test
Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 10 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.
14 mmHg PneumoperitoneumDiagnostic test
Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.
| Study group | Role | What they receive |
|---|---|---|
| 10 mmHg Pneumoperitoneum | Active comparator | Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 10 mmHg. Receives: Diagnostic Test: 10 mmHg Pneumoperitoneum |
| 14 mmHg Pneumoperitoneum | Active comparator | Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg. Receives: Diagnostic Test: 14 mmHg Pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Lung Ultrasound Score (LUS) Change From Baseline
Perioperative lung aeration loss and atelectasis will be assessed using the Lung Ultrasound Score (LUS) during laparoscopic cholecystectomy performed under two different pneumoperitoneum pressures (10 mmHg vs 14 mmHg). Lung ultrasonography will be performed on predefined anterior and lateral chest wall regions bilaterally. Each lung region will be scored from 0 to 3 according to the degree of aeration loss, and the total LUS will range from 0 to 24. Higher scores indicate greater loss of lung aeration and more severe atelectasis.
Measured: T0: After anesthesia induction and before pneumoperitoneum initiation (baseline); T1: At the end of surgery before extubation; T2: 1 hour after arrival in the post-anesthesia care unit (PACU)
Secondary outcomes (2)
Peak Airway Pressure (cmH₂O)
Intraoperative peak airway pressure (cmH₂O) during laparoscopic cholecystectomy will be measured using the anesthesia ventilator and compared between the low-pressure pneumoperitoneum (10 mmHg) and standard-pressure pneumoperitoneum (14 mmHg) groups.
Measured: T0: Before pneumoperitoneum initiation (baseline); T1: 30 minutes after pneumoperitoneum initiation; T2: At the end of surgery before pneumoperitoneum desufflation
Dynamic Lung Compliance (mL/cmH₂O) Measured by Mechanical Ventilator
Intraoperative dynamic lung compliance (mL/cmH₂O), measured using the anesthesia ventilator, will be compared between low-pressure pneumoperitoneum (10 mmHg) and standard-pressure pneumoperitoneum (14 mmHg) groups during laparoscopic cholecystectomy.
Measured: Baseline (before pneumoperitoneum) and 5, 15, 30, and 45 minutes after pneumoperitoneum initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jun 2026
- Primary completion15 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engin Çetin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Engin Çetin, Kocaeli City Hospital
- Investigators
- Engin Çetin, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609615
- Sponsor's protocol ID
- KSH-ANREA-EC-06
- Status last verified
- Aug 2026
- First submitted
- 17 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turan Civraz AZ, Saracoglu A, Saracoglu KT. Evaluation of the Effect of Pressure-Controlled Ventilation-Volume Guaranteed Mode vs. Volume-Controlled Ventilation Mode on Atelectasis in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Clinical Trial. Medicina (Kaunas). 2023 Oct 7;59(10):1783. doi: 10.3390/medicina59101783.
PubMed 37893501
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Pneumoperitoneum Pressures on Perioperative Atelectasis Assessed by Lung Ultrasound in Laparoscopic Cholecystectomy: A Prospective Randomized Single-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07609615
- Acronym / sponsor ID
- KSH-ANREA-EC-06
- Conditions
- Atelectasis, Perioperative Complication, Pneumoperitoneum
- Keywords
- Atelectasis, Pneumoperitoneum, Perioperative Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Engin ÇetinOther government
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 27 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.
Elective laparoscopic cholecystectomy may lead to perioperative atelectasis due to pneumoperitoneum-related diaphragmatic elevation and impaired respiratory mechanics. Lung ultrasound (LUS) provides a noninvasive bedside method for evaluating perioperative aeration loss. This prospective randomized controlled study aims to compare the effects of low-pressure (10 mmHg) and standard-pressure (14 mmHg) pneumoperitoneum on perioperative atelectasis assessed by LUS in patients undergoing laparoscopic cholecystectomy under general anesthesia. Changes in LUS scores, respiratory mechanics, oxygenation, and postoperative clinical outcomes will also be evaluated.
Detailed description
Elective laparoscopic cholecystectomy may cause perioperative atelectasis due to pneumoperitoneum-related impairment of respiratory mechanics. Lung ultrasound (LUS) is a noninvasive bedside tool that can evaluate perioperative lung aeration loss and atelectasis.
This prospective randomized single-blind controlled trial aims to compare the effects of low-pressure (10 mmHg) and standard-pressure (14 mmHg) pneumoperitoneum on perioperative atelectasis assessed by LUS in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Patients will be randomized into two groups according to pneumoperitoneum pressure level.
LUS assessments will be performed before pneumoperitoneum, at the end of surgery before extubation, and at the postoperative first hour. The primary outcome will be the change in LUS score from baseline to the end of surgery. Secondary outcomes will include respiratory mechanics, oxygenation parameters, postoperative oxygen requirement, postoperative pain, nausea-vomiting, and recovery outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| 10 mmHg Pneumoperitoneum | Active comparator | Diagnostic Test: 10 mmHg PneumoperitoneumPatients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 10 mmHg. |
| 14 mmHg Pneumoperitoneum | Active comparator | Diagnostic Test: 14 mmHg PneumoperitoneumPatients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged between 18 and 65 years
- ASA physical status I-II
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Body mass index (BMI) <30 kg/m²
- Ability to provide written informed consent
Key exclusion criteria (10 listed)
- Chronic pulmonary disease
- Recent respiratory tract infection
- Thoracic deformity or previous thoracic surgery
- Preoperative pulmonary pathology
- Morbid obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 mmHg PneumoperitoneumLaparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 10 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed. | Diagnostic test | 10 mmHg Pneumoperitoneum |
| 14 mmHg PneumoperitoneumLaparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed. | Diagnostic test | 14 mmHg Pneumoperitoneum |
Primary outcome
Total Lung Ultrasound Score (LUS) Change From Baseline
Time frame: T0: After anesthesia induction and before pneumoperitoneum initiation (baseline); T1: At the end of surgery before extubation; T2: 1 hour after arrival in the post-anesthesia care unit (PACU)
Perioperative lung aeration loss and atelectasis will be assessed using the Lung Ultrasound Score (LUS) during laparoscopic cholecystectomy performed under two different pneumoperitoneum pressures (10 mmHg vs 14 mmHg). Lung ultrasonography will be performed on predefined anterior and lateral chest wall regions bilaterally. Each lung region will be scored from 0 to 3 according to the degree of aeration loss, and the total LUS will range from 0 to 24. Higher scores indicate greater loss of lung aeration and more severe atelectasis.
2 secondary outcomes
Peak Airway Pressure (cmH₂O)
Time frame: T0: Before pneumoperitoneum initiation (baseline); T1: 30 minutes after pneumoperitoneum initiation; T2: At the end of surgery before pneumoperitoneum desufflation
Dynamic Lung Compliance (mL/cmH₂O) Measured by Mechanical Ventilator
Time frame: Baseline (before pneumoperitoneum) and 5, 15, 30, and 45 minutes after pneumoperitoneum initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 37893501Turan Civraz AZ, Saracoglu A, Saracoglu KT. Evaluation of the Effect of Pressure-Controlled Ventilation-Volume Guaranteed Mode vs. Volume-Controlled Ventilation Mode on Atelectasis in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Clinical Trial. Medicina (Kaunas). 2023 Oct 7;59(10):1783. doi: 10.3390/medicina59101783.
- Individual participant dataSharing planned: No
Related trials for Atelectasis
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
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.
Engin Çetin principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 mmHg Pneumoperitoneum and 14 mmHg Pneumoperitoneum in people with Atelectasis and Perioperative Complication, run by Engin Çetin 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Lung Ultrasound Score (LUS) Change From Baseline (time frame: T0: After anesthesia induction and before pneumoperitoneum initiation (baseline); T1: At the end of surgery before extubation; T2: 1 hour after arrival in the post-anesthesia care unit (PACU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07609615, which also lists 1 linked publication.
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 30 Sep 2026.