一氧化氮对体外膜肺辅助呼吸机所致膈肌功能障碍的机制
2024年10月25日 更新者：Zhongnan Hospital
该临床试验的目的是探讨NO治疗对ECMO辅助机械通气后膈肌功能的影响。 我们预计总共招募80名患者，他们将接受机械通气和机械通气联合ECMO治疗。 根据适应症，他们将接受或不接受治疗。 在ECMO辅助机械通气+NO治疗组中，受试者将被随机分配接受通过呼吸机或膜式氧合器进行NO治疗。 它旨在回答的主要问题是：
- 观察ECMO辅助机械通气时通过呼吸机或膜式氧合器不同NO插入方式对呼吸机诱发性膈肌功能障碍（VIDD）发生发展的影响及潜在治疗效果。
- 探讨NO治疗对ECMO辅助机械通气后VIDD发生发展的潜在关键分子机制。
研究概览
研究类型
观察性的
注册 (估计的)
80
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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Hubei
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Wuhan、Hubei、中国、430071
- Zhongnan Hospital of Wuhan 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
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
急诊病房接受或不接受 ECMO 辅助的机械通气患者
描述
纳入标准：
- 年龄≥18岁；
- 我们急诊科的气管插管；
- 预计生存时间≥72小时；
- 家属同意参加并签署知情同意书。
排除标准：
- 孕妇；
- 患有膈疝或其他已知的膈疾病和损伤的患者；
- 3个月内接受过机械通气治疗的患者；
- 胸部或腹部肿瘤侵犯膈肌；
- 大量腹水使膈肌位置升高；
- 上呼吸道畸形；
- 外伤导致胸部塌陷等。
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
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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隔膜功能
大体时间：我们在机械通气后1小时（1h）内开始POCUS，并分别在6h、12h、24h、48h、72h、96h、120h、144h和168h连续监测膈肌功能。如果患者死亡，POCUS 将终止。
|
机械通气过程中连续 POCUS 监测膈肌功能，包括膈肌厚度、膈肌增厚分数、膈肌偏移等
|
我们在机械通气后1小时（1h）内开始POCUS，并分别在6h、12h、24h、48h、72h、96h、120h、144h和168h连续监测膈肌功能。如果患者死亡，POCUS 将终止。
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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炎症细胞因子
大体时间：第1、2、3、4、5、6、7天的固定时间点。
|
TNF-α、IL-1β、IL-6、IL-8、IL-10等
|
第1、2、3、4、5、6、7天的固定时间点。
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氧化应激标记物
大体时间：第1、2、3、4、5、6、7天的固定时间点。
|
ROS、SOD、MDA、GSH等
|
第1、2、3、4、5、6、7天的固定时间点。
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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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)
2024年1月16日
初级完成 (估计的)
2025年9月30日
研究完成 (估计的)
2025年12月30日
研究注册日期
首次提交
2024年10月25日
首先提交符合 QC 标准的
2024年10月25日
首次发布 (实际的)
2024年10月28日
研究记录更新
最后更新发布 (实际的)
2024年10月28日
上次提交的符合 QC 标准的更新
2024年10月25日
最后验证
2024年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.