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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-KAEK-43 | Other Identifier | ISTANBUL PROVINCIAL DIRECTORATE OF HEALTH KOŞUYOLU HIGH SPECIALIZATION EDUCATION AND CLINICAL RESEARCH ETHICS COMMITTEE |
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This study is an observational clinical investigation designed to evaluate perioperative lung aeration in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. The primary objective is to assess lung status using lung ultrasound in patients aged 18 to 65 years.
A total of 80 volunteer participants will be enrolled. Lung aeration will be evaluated using lung ultrasound scoring before and after surgery. Patient demographic characteristics, medical history, intraoperative airway pressure values, and perioperative lung ultrasound scores will be recorded for analysis.
This study is conducted solely for research purposes and does not involve any drug intervention. All patients will receive standard perioperative care as determined by their attending anesthesiologist and surgical team, with no deviation from routine clinical practice. Participation is voluntary, and patients may withdraw from the study at any time without affecting their medical care.
Perioperative atelectasis is a frequent consequence of general anesthesia and represents a major contributor to postoperative pulmonary complications. Anesthesia-induced loss of functional residual capacity, impaired diaphragmatic movement, and altered ventilation-perfusion matching predispose dependent lung regions to alveolar collapse. These effects are further amplified during laparoscopic surgery due to pneumoperitoneum-induced increases in intra-abdominal pressure, patient positioning, and the routine use of high fractions of inspired oxygen. Even in patients without preexisting pulmonary disease, these factors may result in clinically significant atelectasis during and after surgery.
Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive surgical procedures and serves as a standardized clinical model to investigate perioperative respiratory strategies. Pneumoperitoneum and reverse Trendelenburg positioning during this procedure lead to cephalad displacement of the diaphragm, reduced lung compliance, and regional ventilation heterogeneity, thereby increasing the risk of perioperative atelectasis.
Alveolar recruitment maneuvers are ventilation strategies aimed at reopening collapsed alveoli by temporarily increasing transpulmonary pressure. When applied appropriately, recruitment maneuvers may improve lung aeration, enhance oxygenation, and increase respiratory system compliance. Several studies have demonstrated the beneficial effects of recruitment maneuvers during laparoscopic surgery; however, the optimal timing of these maneuvers remains controversial. The period immediately before extubation is particularly vulnerable to lung derecruitment, and applying a recruitment maneuver at this time may help restore lung aeration and reduce early postoperative atelectasis.
Lung ultrasound has emerged as a reliable, noninvasive, and bedside imaging modality for the assessment of lung aeration. The Lung Ultrasound Score (LUS) allows semi-quantitative evaluation of aeration loss by systematically examining predefined thoracic regions. LUS has been validated against computed tomography and has demonstrated high sensitivity in detecting perioperative atelectasis, making it well suited for use in the intraoperative and immediate postoperative period.
In this prospective clinical study, adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be evaluated to determine the effect of an alveolar recruitment maneuver applied immediately before extubation on perioperative atelectasis. Lung aeration will be assessed using lung ultrasound at predefined time points, and changes in the Lung Ultrasound Score will be used as the primary indicator of atelectasis. Secondary outcomes will include oxygenation parameters and basic respiratory variables.
This study aims to provide objective ultrasound-based evidence regarding the effectiveness of pre-extubation recruitment maneuvers in reducing perioperative atelectasis. The findings may contribute to the optimization of lung-protective ventilation strategies in routine anesthetic practice and support the integration of lung ultrasound into perioperative respiratory monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Extubation Recruitment Group | Patients undergoing laparoscopic cholecystectomy in whom a standardized alveolar recruitment maneuver is applied prior to extubation, with perioperative lung aeration evaluated using lung ultrasound score. | ||
| Standard Ventilation Group | Patients undergoing laparoscopic cholecystectomy managed with standard mechanical ventilation without application of a recruitment maneuver. Lung aeration is evaluated perioperatively using lung ultrasound scoring. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Lung Ultrasound Score (LUS) | Lung ultrasound score (LUS) assessed using a 12-zone scanning technique. Each zone is scored from 0 (normal aeration, A-lines) to 3 (lung consolidation). Total score ranges from 0 to 36, with higher scores indicating worse lung aeration. Change calculated as difference from baseline (T0) to T1 and T2. | Baseline (T0), 30 minutes after pneumoperitoneum (T1), and 30 minutes after desufflation (T2) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult patients aged 18 to 65 years who are scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia. Eligible participants have a body mass index below 30 kg/m² and are classified as American Society of Anesthesiologists (ASA) physical status I-III. All participants provide written informed consent prior to enrollment. Patients undergoing emergency surgery or with significant comorbidities requiring ASA physical status IV are excluded.
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| Name | Affiliation | Role |
|---|---|---|
| doga meric yukselen, MD | ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL | Study Director |
| elif acar deger, MD | ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL | Study Chair |
| oznur demiroluk, MD | ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL | Study Chair |
| arzu yildirim ar, MD | ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL | Study Chair |
| arsen gungor ay, MD | ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL | Study Director |
| cansu ofluoglu, MD | ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital | Istanbul | Istanbul | 34000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35778701 | Result | Liu Y, Wang J, Geng Y, Zhang Y, Su H, Yang Y. The effect of ultrasound-guided lung recruitment maneuvers on atelectasis in lung-healthy patients undergoing laparoscopic gynecologic surgery: a randomized controlled trial. BMC Anesthesiol. 2022 Jul 1;22(1):200. doi: 10.1186/s12871-022-01742-1. | |
| 32682397 | Result |
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Individual participant data will not be shared.
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All participants who met the eligibility criteria were enrolled and assigned to the study groups. No participants were excluded prior to assignment.
Participants were prospectively recruited from adult patients scheduled for elective laparoscopic cholecystectomy at a tertiary care hospital according to predefined inclusion and exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Protective Ventilation Group | Participants in this group received lung-protective mechanical ventilation during laparoscopic cholecystectomy, including low tidal volume ventilation with positive end-expiratory pressure. |
| FG001 | Conventional Ventilation Group | Participants in this group received conventional mechanical ventilation during laparoscopic cholecystectomy according to standard institutional practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline analysis population was identical to the population assigned to the study groups in the participant flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | Protective Ventilation Group | Participants in this group received lung-protective mechanical ventilation during laparoscopic cholecystectomy, including low tidal volume ventilation with positive end-expiratory pressure. |
| BG001 | Conventional Ventilation Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of participants at the time of enrollment, measured in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Lung Ultrasound Score (LUS) | Lung ultrasound score (LUS) assessed using a 12-zone scanning technique. Each zone is scored from 0 (normal aeration, A-lines) to 3 (lung consolidation). Total score ranges from 0 to 36, with higher scores indicating worse lung aeration. Change calculated as difference from baseline (T0) to T1 and T2. | No participants were excluded from analysis. | Posted | Mean | Standard Deviation | points | Baseline (T0), 30 minutes after pneumoperitoneum (T1), and 30 minutes after desufflation (T2) |
|
From anesthesia induction through hospital discharge (approximately 3-5 days postoperatively)
Adverse events were monitored from the time of anesthesia induction until hospital discharge. All respiratory complications and events requiring intervention were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Protective Ventilation Group | Participants in this group received lung-protective mechanical ventilation during laparoscopic cholecystectomy, including low tidal volume ventilation with positive end-expiratory pressure. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Postoperative atelectasis |
Single-center design limits generalizability. Study was unblinded due to the nature of ventilation protocols. Lung ultrasound scoring may have inter-observer variability despite standardized training. Long-term outcomes beyond hospital discharge were not assessed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Name: Cansu Oflıuoglu, MD Official Title: Principal Investigator, Department of Anesthesiology | Fatih Sultan Mehmet Training and Research Hospital | +905358640564 | cansuakin.iu@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 28, 2025 | Jan 19, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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No biological samples will be taken from the patients.
| Kim BR, Lee S, Bae H, Lee M, Bahk JH, Yoon S. Lung ultrasound score to determine the effect of fraction inspired oxygen during alveolar recruitment on absorption atelectasis in laparoscopic surgery: a randomized controlled trial. BMC Anesthesiol. 2020 Jul 18;20(1):173. doi: 10.1186/s12871-020-01090-y. |
Participants in this group received conventional mechanical ventilation during laparoscopic cholecystectomy according to standard institutional practice. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Biological sex of participants as recorded at enrollment | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Body Mass Index calculated as weight in kilograms divided by height in meters squared (kg/m²) | Mean | Standard Deviation | kg/m² |
|
| Conventional Ventilation Group |
Participants in this group received conventional mechanical ventilation during laparoscopic cholecystectomy according to standard institutional practice. |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 3 |
| 40 |
| EG001 | Conventional Ventilation Group | Participants in this group received conventional mechanical ventilation during laparoscopic cholecystectomy according to standard institutional practice. | 0 | 40 | 0 | 40 | 12 | 40 |
|
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