Effect of Recruitment Maneuver on Postoperative Atelectasis Assessed by Lung Ultrasound in Laparoscopic Cholecystectomy

NCT ID: NCT07324122

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-09

Study Completion Date

2025-10-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Perioperative Atelectasis During Laparoscopic Cholecystectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia
* Age between 18 and 65 years
* Body mass index (BMI) \< 30 kg/m²
* American Society of Anesthesiologists (ASA) physical status classification I-III
* Provision of written informed consent

Exclusion Criteria

* Refusal to participate in the study
* Emergency surgical procedures
* Body mass index (BMI) ≥ 30 kg/m²
* American Society of Anesthesiologists (ASA) physical status classification IV
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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doga meric yukselen, MD

Role: STUDY_DIRECTOR

ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL

elif acar deger, MD

Role: STUDY_CHAIR

ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL

oznur demiroluk, MD

Role: STUDY_CHAIR

ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL

arzu yildirim ar, MD

Role: STUDY_CHAIR

ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL

arsen gungor ay, MD

Role: STUDY_DIRECTOR

ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL

cansu ofluoglu, MD

Role: PRINCIPAL_INVESTIGATOR

ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL

Locations

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Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 35778701 (View on PubMed)

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.

Reference Type RESULT
PMID: 32682397 (View on PubMed)

Other Identifiers

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2025-KAEK-43

Identifier Type: OTHER

Identifier Source: secondary_id

FSMTRHLUS

Identifier Type: -

Identifier Source: org_study_id

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