输尿管镜全麻碎石术暂停机械通气 (TA-fURS)
2026年6月11日 更新者：Yi Zhou、Chinese Medical Association
Transient Apnea to Stabilize Renal Motion During Flexible Ureteroscopic Lithotripsy: A Randomized Controlled Trial of Efficiency and Physiological Safety
对于部分输尿管上段和肾结石，输尿管镜碎石术需要在全身麻醉下进行，中断机械通气，可能导致高碳酸血症和缺氧。
在这项研究中，研究人员假设在 1 L/min 100% 氧气的呼吸回路中加入 10 cmH2O PEEP 可能会延长通气暂停时间，但对血液中二氧化碳的滞留没有影响。
研究概览
地位
完全的
详细说明
对于一些输尿管上段和肾结石，无论是在硬膜外麻醉还是机械通气全身麻醉下，输尿管镜碎石术常因患者的呼吸运动而受阻。
故全身麻醉下间歇暂停机械通气可保证手术的连续、成功进行。
但这可能会导致高碳酸血症和缺氧。
迄今为止，很少有研究关注暂停呼吸导致血液内环境的变化。
在这项研究中，研究人员假设在 1 L/min 100% 氧气的呼吸回路中加入 10 cmH2O PEEP 可能会延长通气暂停时间，但对血液中二氧化碳的滞留没有影响。
研究类型
介入性
注册 (实际的)
150
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200433
- Changhai Hospital, Naval Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
ASA I~III全身麻醉签署知情同意书
排除标准：
怀孕或计划生育的 ASA IV 或 V 妇女
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Regular Mechanical Ventilation
Participants received regular mechanical ventilation during flexible ureteroscopic laser lithotripsy under general anesthesia.
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Standard controlled mechanical ventilation was maintained during the active lithotripsy phase according to routine anesthetic practice.
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有源比较器：Small Tidal-Volume Ventilation
Participants received small tidal-volume controlled ventilation during active flexible ureteroscopic laser lithotripsy to reduce respiration-related renal motion while maintaining clinically acceptable oxygenation and ventilation.
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Controlled ventilation with a reduced tidal-volume strategy was applied during active lithotripsy under continuous anesthetic monitoring.
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实验性的：Transient Apnea
Participants underwent transient apnea during active flexible ureteroscopic laser lithotripsy after adequate preoxygenation and confirmation of physiologic stability by the anesthesiologist.
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Transient apnea was applied during active laser lithotripsy to reduce respiration-related renal motion.
Apnea was initiated after adequate preoxygenation and confirmation of physiologic stability.
Apnea was terminated if SpO₂ was <90%, systolic blood pressure was >160 mmHg or <80 mmHg, heart rate was <50 beats/min, obvious arrhythmia occurred, hemodynamic instability developed, or the attending anesthesiologist had any safety concern.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Active lithotripsy efficiency
大体时间：Intraoperative
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Active lithotripsy efficiency was defined as CT-based stone volume divided by active lithotripsy time.
Stone volume was calculated from stone length, width, and depth using the ellipsoid formula.
Active lithotripsy time was defined as the duration of active laser fragmentation or dusting and excluded ureteral access, endoscopic inspection, stent placement, and other non-lithotripsy procedural time.
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Intraoperative
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Active lithotripsy time
大体时间：Intraoperative
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Active lithotripsy time was defined as the duration of active laser fragmentation or dusting during flexible ureteroscopic lithotripsy.
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Intraoperative
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Total operative time
大体时间：Intraoperative
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Total operative time was defined as the time from endoscope insertion to completion of the procedure.
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Intraoperative
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Stone-free status on postoperative day 1 CT
大体时间：Postoperative day 1
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Stone-free status was assessed using CT on postoperative day 1.
Non-stone-free status was defined as any residual fragment >2 mm.
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Postoperative day 1
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Arterial pH
大体时间：Baseline to 3 minutes after resumption of ventilation
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Arterial pH was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation.
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Baseline to 3 minutes after resumption of ventilation
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Arterial carbon dioxide tension
大体时间：Baseline to 3 minutes after resumption of ventilation
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Arterial PaCO₂ was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation.
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Baseline to 3 minutes after resumption of ventilation
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Arterial oxygen tension
大体时间：Baseline to 3 minutes after resumption of ventilation
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Arterial PaO₂ was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation.
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Baseline to 3 minutes after resumption of ventilation
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Arterial lactate
大体时间：Baseline to 3 minutes after resumption of ventilation
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Arterial lactate was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation.
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Baseline to 3 minutes after resumption of ventilation
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Base excess
大体时间：Baseline to 3 minutes after resumption of ventilation
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Base excess was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation.
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Baseline to 3 minutes after resumption of ventilation
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Protocol-defined interruption of transient apnea
大体时间：Intraoperative
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Protocol-defined interruption was recorded when transient apnea was discontinued because of SpO₂ <90%, systolic blood pressure >160 mmHg or <80 mmHg, heart rate <50 beats/min, obvious arrhythmia, hemodynamic instability, or anesthesiologist concern.
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Intraoperative
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Postoperative complications
大体时间：Up to 3 months after surgery
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Postoperative complications were recorded and graded according to the Clavien-Dindo classification.
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Up to 3 months after surgery
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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手术持续时间
大体时间：从手术开始到手术结束
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我们记录操作的持续时间
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从手术开始到手术结束
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恢复时间
大体时间：从麻醉结束到意识恢复
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我们记录患者在停止麻醉后需要多长时间才能按照我们的命令行动。
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从麻醉结束到意识恢复
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术中意识
大体时间：从麻醉开始到手术结束
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我们会记录patinets在手术过程中是否有记忆，即术中意识。
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从麻醉开始到手术结束
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年6月15日
初级完成 (实际的)
2024年12月27日
研究完成 (实际的)
2025年4月16日
研究注册日期
首次提交
2013年4月2日
首先提交符合 QC 标准的
2013年4月11日
首次发布 (估计的)
2013年4月19日
研究记录更新
最后更新发布 (实际的)
2026年6月15日
上次提交的符合 QC 标准的更新
2026年6月11日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- SMV-312
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be publicly shared because the dataset contains patient-level perioperative, imaging, and physiologic monitoring data, and public sharing was not included in the original informed consent.
Deidentified data underlying the published results may be made available from the corresponding investigator upon reasonable request and after institutional ethics approval.
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