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临床试验/NCT07324122
NCT07324122已完成不适用

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

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Change in Lung Ultrasound Score (LUS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Alveolar recruitment manoeuvre (Procedure)

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.

干预措施: Lung-protective ventilation with lung ultrasound assessment (Procedure)

结局指标

主要结局

Change in Lung Ultrasound Score (LUS)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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