急性呼吸衰竭幸存者误吸 2
2023年7月17日 更新者：University of Colorado, Denver
急性呼吸衰竭幸存者的误吸
这项研究的目的是了解更多有关吞咽问题的信息，这些问题可能发生在病重且需要机器帮助他们呼吸的患者身上。
研究概览
详细说明
这项研究的目的是了解更多有关吞咽问题的信息，这些问题可能发生在病重且需要机器帮助他们呼吸的患者身上。
患者被要求参加这项研究，因为他们自己呼吸有问题，因此需要一种叫做呼吸机的机器的帮助。
为了让这种呼吸机将空气推入肺部，患者需要在喉咙中放置一根称为气管插管的管子。
放置这种气管导管的过程称为插管。
管子现已被移除，这是一个称为拔管的过程。
有时，接受过气管插管的人可能会在一段时间内难以吞咽食物和液体。
这种疾病称为拔管后吞咽困难 (PED)。
PED 是一种严重的疾病，可能导致食物或液体从口腔进入肺部。
这可能会导致进一步的肺部问题。
鉴于这种风险，医生有时会建议 PED 患者避免进食或饮水，或者使用饲管。
目前，没有人知道患者患 PED 的频率、发病原因或检测 PED 的最佳方法。
标准护理涉及临床医生进行有根据的猜测。
这项研究旨在确定使用和不使用小型相机观察患者吞咽是否是检测 PED 的准确方法。
研究类型
介入性
注册 (估计的)
855
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。
学习联系方式
- 姓名：Jeff McKeehan, RN,MSN
- 电话号码：3037246080
- 邮箱：jeffrey.mckeehan@cuanschutz.edu
学习地点
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California
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Stanford、California、美国、94305
- 招聘中
- Stanford Univerity
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接触：
- Joseph Levitt, MD, MS
- 邮箱：JLevitt@stanford.edu
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首席研究员：
- Joseph Levitt, MD, MS
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Colorado
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Aurora、Colorado、美国、80045
- 招聘中
- University of Colorado
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接触：
- Anna Matheson, RN, BSN
- 电话号码：303-724-6377
- 邮箱：anna.matheson@cuanschutz.edu
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接触：
- Jeffrey McKeehan, RN, MSN
- 电话号码：3037246080
- 邮箱：Jeffrey.McKeehan@cuanschutz.edu
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首席研究员：
- Marc Moss, MD
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Connecticut
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New Haven、Connecticut、美国、06519
- 招聘中
- Yale University
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接触：
- Jonathan Siner, MD
- 邮箱：Jonathan.Siner@yale.edu
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首席研究员：
- Jonathan Siner, MD
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Massachusetts
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Boston、Massachusetts、美国、02118
- 招聘中
- Boston University
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接触：
- Gintas Krisciunas, MPH, MS
- 邮箱：Gintas.Krisciunas@bmc.org
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首席研究员：
- Gintas Krisciunas, MPH, MS
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首席研究员：
- Susan Langmore, 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
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 入住 ICU。
- 使用气管插管进行机械通气超过 48 小时。
排除标准：
- 禁忌肠内营养给药。
- 既往有吞咽困难或误吸史。
- 预先存在的或急性原发性中枢或周围神经肌肉疾病。
- 存在慢性气管切开术（在入住 ICU 之前存在）。
- 预先存在的头颈癌或手术。
- 凝血障碍导致不受控制的鼻腔或咽部出血。
- 根据意识模糊评估方法 (CAM-ICU) 评估的拔管后谵妄超过 72 小时。
- 拔管超过 72 小时。
- 无法获得患者或适当代理人的知情同意。
- 年龄 < 18 岁。
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：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：急性呼吸衰竭幸存者的误吸
所有参与者将在拔管前 72 小时内接受气管超声检查，收集人口统计信息和医院临床信息，并在 24 小时内进行 3 次筛查测试（研究定义的算法测试、3 盎司水吞咽测试、TOR-BSST）解决吞咽功能问题拔管后和吞咽纤维内窥镜检查 (FEES) 检查。
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3-Screenings Protocol 是一种改良的床边吞咽检查 (BSE)，由一项研究开发的五项决策树算法组成，包括语音质量评估和 2 盎司水的一致性评估，耶鲁吞咽测试，使用 3 盎司水进行评分吞咽试验 (3-WST) 和多伦多床边吞咽筛查试验 (TOR-BSST)。
其他名称：
设计用于评估喉部结构的薄而灵活的内窥镜通过鼻子到达口咽部，可以看到喉部结构、舌根和咽部。
如果需要，将给予 4% 的局部利多卡因和/或羟甲唑啉 (Afrin)。
然后将直接用 6 份 5 毫升的食物推注来评估吞咽。
将允许所有患者自发吞咽，无需口头命令进行吞咽。
将记录检查视频，并由 3 名不同的观察员（一名肺科医生和两名语言病理学家 (SLP)）独立指定是否存在吞咽困难。
此过程需要 5-10 分钟。
然后相机将被移除。
其他名称：
气管超声显像，测量拔管前72小时内气管直径与气管插管（ETT）尺寸比值
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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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在 FEES 上经历任何喂养一致性的参与者的百分比
大体时间：从拔管第 1 天到出院，预计在 28 天内
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FEES 的抽吸（PAS 分数≥6）和任何喂养浓度。
PAS 评分 ≥ 6 包括无声和非无声误吸患者。
使用 FEES ≥ 6 的 PAS 截止分数，患者将根据五种一致性中的任何一种进行抽吸分层。
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从拔管第 1 天到出院，预计在 28 天内
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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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经历非无声吸气的参与者百分比
大体时间：从拔管第 1 天到出院，预计在 28 天内
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我们会将吸气患者分为非无声 (PA = 6-7) 和无声 (PAS=8) 吸气，并确定推注和一致性类型的最大 PAS 分数。
FEES 的抽吸（PAS 分数≥6）和任何喂养浓度。
PAS 评分 ≥ 6 包括无声和非无声误吸患者。
使用 FEES ≥ 6 的 PAS 截止分数，患者将根据五种一致性中的任何一种进行抽吸分层。
我们还将确定推注和一致性类型的最大 PAS 分数。
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从拔管第 1 天到出院，预计在 28 天内
|
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经历无声吸气的参与者百分比
大体时间：从拔管第 1 天到出院，预计在 28 天内
|
我们会将吸气患者分为非无声 (PA = 6-7) 和无声 (PAS=8) 吸气，并确定推注和一致性类型的最大 PAS 分数。
FEES 的抽吸（PAS 分数≥6）和任何喂养浓度。
PAS 评分 ≥ 6 包括无声和非无声误吸患者。
使用 FEES ≥ 6 的 PAS 截止分数，患者将根据五种一致性中的任何一种进行抽吸分层。
我们还将确定推注和一致性类型的最大 PAS 分数。
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从拔管第 1 天到出院，预计在 28 天内
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经历拔管后临床喉水肿的参与者百分比
大体时间：拔管后24小时内
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我们将喉头水肿定义为拔管后24小时内的上呼吸道阻塞。
轻度喉头水肿定义为伴有呼吸窘迫的喘鸣，呼吸窘迫定义为吸气相延长且 FEES 检查出现水肿。
严重喉头水肿将定义为继发于 FEES 检查期间可见的上呼吸道阻塞而需要气管再插管的严重呼吸窘迫
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拔管后24小时内
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机械通气时间
大体时间：从插管到拔管接受机械通气，平均预计在 2-14 天内
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我们还将以天为单位收集机械通气的总时长
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从插管到拔管接受机械通气，平均预计在 2-14 天内
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从机械通气中解放出来所需的时间
大体时间：从插管到拔管接受机械通气，平均预计在 2-14 天内
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我们还将以天为单位收集机械通气解放过程的总时长
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从插管到拔管接受机械通气，平均预计在 2-14 天内
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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：Marc Moss, MD、University of Colorado, Denver
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。
一般刊物
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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)
2021年12月15日
初级完成 (估计的)
2025年12月15日
研究完成 (估计的)
2025年12月15日
研究注册日期
首次提交
2021年10月25日
首先提交符合 QC 标准的
2021年10月25日
首次发布 (实际的)
2021年11月5日
研究记录更新
最后更新发布 (实际的)
2023年7月18日
上次提交的符合 QC 标准的更新
2023年7月17日
最后验证
2023年7月1日
更多信息
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