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

NCT07324122 | Completed Results DMC

• 2 other identifiers: FSMTRHLUS2025-KAEK-43
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Atelectasis

Keywords

Protective lung ventilation; Laparoscopic surgery; Alveolar recruitment; Pneumoperitoneum; Cholecystectomy; Perioperative respiratory complications; Lung ultrasound score; Lung ultrasound; LUS

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 35778701 RESULT

• 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.

  PMID: 32682397 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

No biological samples will be taken from the patients.

MeSH Terms

Conditions

Pulmonary Atelectasis; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Peritoneal Diseases; Digestive System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Name: Cansu Oflıuoglu, MD Official Title: Principal Investigator, Department of Anesthesiology
• Organization: Fatih Sultan Mehmet Training and Research Hospital

cansuakin.iu@gmail.com

+905358640564

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 7, 2026
• Study Start: April 9, 2025
• Primary Completion: October 9, 2025
• Study Completion: October 10, 2025
• Last Updated: March 4, 2026
• Results First Posted: February 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)