跳至主要内容
临床试验/NCT07044661
NCT07044661尚未招募不适用

Effect of Bilateral vs. Unilateral Alveolar Recruitment on Gas Exchange in Lung Resection

Yonsei University2 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2025年7月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
198
试验地点
2
主要终点
PaO₂/FiO₂ at 60 minutes after ARM

研究概览

简要总结

"One-lung ventilation (OLV) is an essential technique during thoracic surgery but preventing atelectasis during OLV remains a key challenge in thoracic anesthesia.

Several previous randomized controlled trials have demonstrated that alveolar recruitment maneuvers (ARMs) can significantly reduce driving pressure, peak airway pressure, plateau pressure, and anatomical dead space. However, the optimal method for implementing ARMs has not yet been standardized, as the timing and target of ARM application vary among studies. Some protocols involve applying ARMs to both lungs immediately prior to the initiation of OLV (bilateral ARM), while others apply ARMs solely to the non-operative lung after OLV has begun (unilateral ARM). Bilateral ARM may provide prolonged improvement in gas exchange but carry the risk of insufficient collapse of the operative lung. Conversely, unilateral ARM may facilitate better collapse of the operative lung compared to bilateral ARMs, though potentially at the expense of gas exchange. To date, no study has directly compared these two approaches. This study aims to compare and evaluate the effects of bilateral versus unilateral ARM performed immediately prior to thoracic incision on intraoperative gas exchange and the incidence of intraoperative and postoperative complications."

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • -Adult patients aged 20 to 80 years scheduled for thoracoscopic lung resection.
  • American Society of Anesthesiologists (ASA) physical status classification of I to III.

排除标准

  • Anticipated duration of one-lung ventilation (OLV) less than 1 hour.
  • Diagnosis of heart failure.
  • History of pneumothorax or radiologic evidence of pulmonary blebs or bullae prior to surgery.
  • Patients receiving supplemental oxygen therapy or mechanical ventilation prior to surgery.
  • Dropout Criteria
  • Actual duration of OLV less than 1 hour.
  • Surgery is canceled or converted to an open thoracotomy or another surgical approach.
  • Inability to maintain peripheral oxygen saturation ≥90% despite adjustments in inspired oxygen fraction.
  • Inability to maintain ventilator settings due to extensive pulmonary adhesions.

结局指标

主要结局

PaO₂/FiO₂ at 60 minutes after ARM

时间窗: PaCO₂ is assessed by arterial blood gas analysis at 60 minutes after ARM.

We analyze whether different methods of ARM result in significant differences in the PaO₂/FiO₂ ratio measured at 60 minutes after the initiation of one-lung ventilation (OLV60).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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