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: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This single-centre, prospective, randomized, parallel-group controlled trial evaluated whether alveolar recruitment manoeuvres (RMs) added to a lung-protective ventilation strategy improve perioperative lung aeration in adults undergoing elective laparoscopic cholecystectomy under general anaesthesia. Eighty patients (ASA I-III) were allocated 1:1 to an RM group or a control group. Both groups received identical low-tidal-volume ventilation with 5 cmH₂O PEEP; the RM group additionally received a standardized stepwise recruitment manoeuvre at two points-after establishment of pneumoperitoneum and again before extubation-with PEEP returned to 5 cmH₂O after each manoeuvre. Lung aeration was assessed by an 8-zone lung ultrasound (LUS) protocol at five predefined perioperative time points. The primary outcome was the perioperative composite LUS score trajectory. Peripheral oxygen saturation, mean arterial pressure, and heart rate were assessed as safety outcomes.

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 8-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)

Recruitment manoeuvre (RM) group

EXPERIMENTAL

Patients receive low-tidal-volume ventilation (6-8 mL/kg predicted body weight) with 5 cmH₂O PEEP, plus a standardized stepwise alveolar recruitment manoeuvre applied at two time points: after establishment of CO₂ pneumoperitoneum and again before extubation. Each manoeuvre uses a fixed driving pressure of 15 cmH₂O with PEEP incremented stepwise (5 → 10 → 15 cmH₂O, 10-15 seconds per step); PEEP is returned to 5 cmH₂O after each manoeuvre. Lung aeration is assessed by 8-zone lung ultrasound at five predefined perioperative time points.

Procedure: Alveolar recruitment manoeuvre

Control group (no recruitment manoeuvre)

ACTIVE COMPARATOR

Patients receive low-tidal-volume ventilation (6-8 mL/kg predicted body weight) with 5 cmH₂O PEEP maintained throughout the intraoperative period, without any alveolar recruitment manoeuvre. All other anaesthetic and surgical management is identical to the RM group. Lung aeration is assessed by 8-zone lung ultrasound at the same five predefined perioperative time points.

Procedure: Lung-protective ventilation with lung ultrasound assessment

Interventions

Alveolar recruitment manoeuvre PROCEDURE

A standardized stepwise alveolar recruitment manoeuvre applied at two intraoperative time points: after establishment of CO₂ pneumoperitoneum and again before extubation. Each manoeuvre uses a fixed driving pressure of 15 cmH₂O with PEEP incremented stepwise (5 → 10 → 15 cmH₂O, 10-15 seconds per step), then PEEP returned to 5 cmH₂O. The manoeuvre is terminated if peak inspiratory pressure exceeds 35 cmH₂O or haemodynamic instability occurs. Applied in addition to low-tidal-volume protective ventilation.

Recruitment manoeuvre (RM) group

Lung-protective ventilation with lung ultrasound assessment PROCEDURE

Volume-controlled low-tidal-volume ventilation (6-8 mL/kg predicted body weight) with 5 cmH₂O PEEP and FiO₂ titrated to maintain SpO₂ ≥ 95%, applied to both groups. Perioperative lung aeration is assessed using a standardized 8-zone lung ultrasound protocol at five predefined time points (preoperative baseline, 5 minutes post-induction, post-pneumoperitoneum, immediately post-extubation, and 30 minutes after PACU arrival) by blinded assessors independent of ventilation management.

Control group (no recruitment manoeuvre)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia
• Age between 18 and 75 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

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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm parallel-group randomized controlled trial. Eligible patients were allocated 1:1 to a recruitment manoeuvre group or a control group using a computer-generated randomization sequence with allocation concealment by sequentially numbered, sealed, opaque envelopes. Both groups received identical low-tidal-volume ventilation with 5 cmH₂O PEEP; the groups differed only by the application of standardized alveolar recruitment manoeuvres in the intervention group.

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 7, 2026
• Study Start: April 25, 2025
• Primary Completion: October 25, 2025
• Study Completion: October 26, 2025
• Last Updated: August 5, 2026
• Results First Posted: February 19, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)