术后呼吸和活动监测
2024年1月25日 更新者：University of Colorado, Denver
这项研究计划更多地了解手术后患者的具体呼吸和活动建议。
腹部手术后将对参与者进行监测，以确定哪些活动可以帮助他们更好地呼吸并减少术后并发症。
研究概览
详细说明
研究人员将研究接受选择性腹部手术且术后肺部并发症风险至少为中等的成年人。
将使用记录呼吸模式（呼吸量和频率）以及身体位置和动作的设备对参与者的胸部和大腿进行监测。 这些监视器将被放置在麻醉后护理室 (PACU) 的皮肤上，并持续三天，或者直到患者能够自由走动或出院（以较早者为准）。 研究人员将结合接受的药物和其他医院病程事件，分析各种活动（例如坐、行走）的频率、持续时间和强度与呼吸和其他临床并发症之间的关联。
研究类型
观察性的
注册 (估计的)
30
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。
学习联系方式
- 姓名：Emily G. Helmer
- 电话号码：(303)-724-2938
- 邮箱：emily.helmer@cuanschutz.edu
学习地点
-
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Colorado
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Aurora、Colorado、美国、80045
- 招聘中
- UC Health
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接触：
- Emily G. Helmer
- 电话号码：303-724-2938
- 邮箱：emily.helmer@cuanschutz.edu
-
首席研究员：
- Ana Fernandez-Bustamante, MD, PhD
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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
科罗拉多大学健康医院 (UCHealth) 18 岁以上接受腹部手术的患者术后肺部并发症 (PPC) 的风险很高。
描述
纳入标准：
- 必须年满 18 岁
- 必须接受腹部手术
- PPC 必须属于高风险（ARISCAT 分数等于或大于 26）
排除标准：
- 任何 18 岁以下的人
- 任何未接受腹部手术的人
- PPC 风险不高的任何人（ARISCAT 分数低于 26）
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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术后监测
ActivPAL 加速计将放置在胸部和大腿上，ExSpiron 监测器放置在胸部，患者将被观察三天，直到完全行走（无论是否有助行器都能够步行 30 米），或直到出院;以先到者为准。
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ExSpiron 胸部监视器将放置在胸部 ActivPAL 加速度计将放置在胸部和大腿
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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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通气不足
大体时间：术后前 3 天
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每小时通气不足的分钟数，定义为 < 预计每分钟通气量的 40%
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术后前 3 天
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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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MV 的可变性
大体时间：术后第 3 天
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每分钟通气量 (MV) 的变异性
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术后第 3 天
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VT 的变异性
大体时间：术后第 3 天
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潮气量 (VT) 的变化
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术后第 3 天
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RR 的可变性
大体时间：术后第 3 天
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呼吸频率的变异性 (RR)
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术后第 3 天
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低MV事件
大体时间：术后第 3 天
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低分钟通气量 (MV) 事件总数
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术后第 3 天
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低潮气量事件
大体时间：术后第 3 天
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低潮气量 (VT) 事件总数
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术后第 3 天
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低RR事件
大体时间：术后第 3 天
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低呼吸频率 (RR) 事件总数
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术后第 3 天
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无低或高 MV 的时间百分比
大体时间：术后第 3 天
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每天无任何低或高分钟通气量 (MV) 的小时百分比
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术后第 3 天
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无低或高 VT 的时间百分比
大体时间：术后第 3 天
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每天没有任何低潮气量或高潮气量 (VT) 的小时百分比
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术后第 3 天
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无低或高 RR 的时间百分比
大体时间：术后第 3 天
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每天不受任何低或高静息率 (RR) 影响的小时数百分比。
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术后第 3 天
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低 MV 持续时间
大体时间：术后第 3 天
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低分钟通气量 (MV) 持续时间
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术后第 3 天
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低VT持续时间
大体时间：术后第 3 天
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低潮气量 (VT) 持续时间
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术后第 3 天
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低 RR 持续时间
大体时间：术后第 3 天
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低呼吸频率 (RR) 持续时间
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术后第 3 天
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高 MV 持续时间
大体时间：术后第 3 天
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每分钟通气量低或高的持续时间 (MV)
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术后第 3 天
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高电视持续时间
大体时间：术后第 3 天
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高潮气量 (VT) 持续时间
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术后第 3 天
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高 RR 持续时间
大体时间：术后第 3 天
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高呼吸频率 (RR) 持续时间
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术后第 3 天
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术后肺部并发症 (PPC) 发生率
大体时间：术后第 7 天
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术后肺部并发症 (PPC) 的发生率
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术后第 7 天
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术后肺部并发症 (PPC) 严重程度
大体时间：术后第 7 天
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将观察术后肺部并发症（PPC）的严重程度。
PPC 严重程度定义为最严重，从 0 级（无）到 4 级（严重）
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术后第 7 天
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手术后到坐的时间
大体时间：术后第 3 天
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手术后患者坐在椅子上所需的时间
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术后第 3 天
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手术后到下床活动的时间
大体时间：术后第 3 天
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患者在有帮助和无帮助的情况下行走所需的时间
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术后第 3 天
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步行总分钟数
大体时间：术后第 3 天
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患者步行的总分钟数
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术后第 3 天
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总步行距离
大体时间：术后第 3 天
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患者的总步行距离（以米为单位）
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术后第 3 天
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行走频率
大体时间：术后第 3 天
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患者起身行走多少次
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术后第 3 天
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躺在床上的时间
大体时间：术后第 3 天
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手术后，患者在床上度过的时间
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术后第 3 天
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坐着的时间
大体时间：术后第 3 天
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手术后，患者坐着的时间
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术后第 3 天
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站立时间
大体时间：术后第 3 天
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手术后，患者站立的时间
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术后第 3 天
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步行时间
大体时间：术后第 3 天
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手术后，患者步行的分钟数
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术后第 3 天
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平均行走速度
大体时间：术后第 3 天
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手术后，患者的平均行走速度
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术后第 3 天
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术后第一天实现独立行走
大体时间：术后第 3 天
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手术后，患者第一天自行下床行走30米
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术后第 3 天
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体力活动任务代谢当量 (MET) 得分
大体时间：术后第 3 天
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手术后，以 MET 测量患者的体力活动强度
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术后第 3 天
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其他并发症
大体时间：术后第 7 天
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任何非呼吸系统并发症的发生率
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术后第 7 天
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不良事件
大体时间：术后第 7 天
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任何不良事件的发生率
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术后第 7 天
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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。
调查人员
- 首席研究员：Ana Fernandez-Bustamante, MD, PhD、University of Colorado Anschutz Medical Campus, University of Colorado Health Hospital
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)
2022年12月22日
初级完成 (估计的)
2024年12月22日
研究完成 (估计的)
2025年6月22日
研究注册日期
首次提交
2023年9月28日
首先提交符合 QC 标准的
2024年1月25日
首次发布 (实际的)
2024年2月2日
研究记录更新
最后更新发布 (实际的)
2024年2月2日
上次提交的符合 QC 标准的更新
2024年1月25日
最后验证
2024年1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.