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Completed

NCT Number: NCT07324122

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

Laparoscopic cholecystectomy under general anaesthesia with CO₂ pneumoperitoneum predictably reduces lung aeration and promotes atelectasis that global monitoring parameters may fail to detect. This trial compared two intraoperative ventilation strategies differing solely in the application of alveolar recruitment manoeuvres, using serial lung ultrasound to quantify regional aeration.

Adults aged 18-75 years, ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy were eligible. Patients undergoing emergency surgery, with severe pre-existing pulmonary disease (e.g., COPD GOLD stage ≥ III, interstitial lung disease) or previous thoracic surgery, who were pregnant, or who required conversion to open surgery were excluded. Eligible participants were randomized 1:1 using a computer-generated sequence, with allocation concealed by sequentially numbered, sealed, opaque envelopes.

All patients received standardized general anaesthesia and volume-controlled ventilation (tidal volume 6-8 mL/kg predicted body weight, PEEP 5 cmH₂O, FiO₂ titrated to SpO₂ ≥ 95%, EtCO₂ 35-40 mmHg). In the RM group, a standardized stepwise recruitment manoeuvre (driving pressure 15 cmH₂O; PEEP incremented 5 → 10 → 15 cmH₂O in 10-15-second steps) was performed twice: first immediately after establishment of CO₂ pneumoperitoneum and surgical positioning, and second after pneumoperitoneum deflation and before extubation. PEEP was returned to 5 cmH₂O after each manoeuvre, identical to the control group, so that the groups differed only by the recruitment manoeuvres and not by sustained PEEP. The control group received no recruitment manoeuvre, with PEEP maintained at 5 cmH₂O throughout. Intra-abdominal pressure was limited to 12 mmHg.

An 8-zone LUS protocol (each hemithorax divided into anterior-upper, anterior-lower, lateral-upper, and lateral-lower regions) was applied at five predefined time points: T1, preoperative baseline; T2, 5 minutes after induction; T3, after pneumoperitoneum establishment and the first recruitment manoeuvre; T4, immediately after extubation and the second recruitment manoeuvre; and T5, 30 minutes after arrival in the post-anaesthesia care unit. LUS examinations were performed by a dedicated team of blinded anaesthesiology specialists independent of intraoperative ventilation management.

The primary outcome was the perioperative composite LUS score trajectory across the five time points, analysed with a linear mixed-effects model (group, time, and group × time interaction). Safety outcomes were peripheral oxygen saturation, mean arterial pressure, and heart rate at each time point.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Lung Ultrasound Score (LUS)

    Time frame: Baseline (T0), 30 minutes after pneumoperitoneum (T1), and 30 minutes after desufflation (T2)

    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.

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Official study title

EVALUATION OF THE EFFECT OF RECRUITMENT MANEUVER ON POSTOPERATIVE ATELECTASIS IN LAPAROSCOPIC CHOLECYSTECTOMY SURGERY USING LUS (LUG ULTRASOUND SCALE)

Acronym: LUNG USG SCORE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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