Effect of Recruitment Maneuver on Postoperative Atelectasis Assessed by Lung Ultrasound in Laparoscopic Cholecystectomy
NCT07324122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-08-05
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
Interventions
- PROCEDURE
-
Alveolar recruitment manoeuvre
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.
- PROCEDURE
-
Lung-protective ventilation with lung ultrasound assessment
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.
Sponsors & Collaborators
-
Fatih Sultan Mehmet Training and Research Hospital
lead OTHER
Principal Investigators
-
doga meric yukselen, MD · ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL
-
elif acar deger, MD · ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL
-
oznur demiroluk, MD · ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL
-
arzu yildirim ar, MD · ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL
-
arsen gungor ay, MD · ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL
-
cansu ofluoglu, MD · ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-25
- Primary Completion
- 2025-10-25
- Completion
- 2025-10-26
Countries
- Turkey (Türkiye)
Study Locations
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