不同虚弱评分对术后谵妄和认知功能障碍的发生率
比较不同虚弱评分与术后谵妄和认知功能障碍发生率的关联
身体虚弱的患者术后并发症发生率、死亡率、住院时间延长、独立性丧失、收容机构增加、术后认知功能障碍 (POCD) 和谵妄 (POD) 的发生率更高。
因此,找到一种合适的衰弱评估工具至关重要,该工具可以纳入我们当地老年围手术期管理的指南和参考。 与此同时,在我们的临床医生中提高对患有 POD、POCD 和其他相关不良结果的虚弱老年人口的认识。
研究概览
详细说明
预期寿命的增加导致老年人口增加,因此老年患者在手术病例中所占比例更大。 但是,他们中的大多数人都很虚弱,患有多种合并症,并且术后容易出现不良后果。 最常见的不良后果是术后精神错乱 (POD),临床医生经常会错过这种情况,而且往往掉以轻心。 如果不加以治疗,将发展为术后认知功能障碍(POCD)。
因此,在术前确定风险因素以最大限度地降低 POD 和 POCD 的风险至关重要。 身体虚弱的患者更可能有预先存在的认知障碍和认知储备减少,因此,他们最容易患上 POCD 和 POD。 Fried Frailty 标准是最常用的虚弱筛查工具之一,它是一种易于访问的工具,主要对患者进行身体筛查和评分。 然而,研究人员建议使用格罗宁根虚弱量表,因为它可以以更全面的方法评估患者,不仅包括身体,还包括患者的视力、发热、营养、合并症、认知、社会心理和活动能力。
方法:
在 2019 年 8 月至 2020 年 1 月的 6 个月期间,将招募在马来亚大学医学中心接受全身或局部麻醉下择期手术的 65 岁以上老年患者进行这项研究。 手术前将对患者进行基线认知评估、营养状况、心理状况和虚弱评分评估。 手术后,将使用 4AT 和 CAM 评估患者至少 5 天或直到患者出院。 认知功能将在术后第 7 天、1 个月和 3 个月通过电话使用 T-MOCA 进行评估。
所有数据将使用 SPSS 进行分析。
研究的影响:
将确定一种合适的虚弱评估工具,供接受择期手术的老年患者术前使用。 然后,该工具将被纳入我们当地的老年围手术期管理协议指南和参考中。
此外,根据这些结果,研究人员希望在我们对老年手术人群的多学科护理中提高对虚弱评估及其与术后谵妄、认知功能障碍和相关不良结果的相关性的认识。
研究类型
注册 (实际的)
联系人和位置
学习地点
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Wilayah Persekutuan Kuala Lumpur
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Kuala Lumpur、Wilayah Persekutuan Kuala Lumpur、马来西亚、50603
- University Malaya
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
纳入标准:
- 年龄 65 岁及以上
- ASA 1 - 3
- 完整的地面站
- 择期手术
- 能够很好地沟通
- 同意
- 手术结束时拔管
排除标准:
- 心脏和神经外科
- 关于影响中枢神经系统的药物
- 入ICU插管继续通气。
- 拒绝同意
- 严重的听力损失
- 无法使用电话/手机进行通讯
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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油炸虚弱表型
这组患者将通过虚弱的 5 个特征进行评估,这 5 个特征是患者的体重减轻、虚弱、疲惫、低活动和身体健康。
被归类为虚弱的患者将具有 3 个以上的标准,中度或虚弱前期将存在 1 或 2 个标准,而健壮的则没有标准。
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这是一项针对择期手术患者的观察性和前瞻性研究,因此不会给予任何干预。
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格罗宁根虚弱指数
GFI 是一个简单的问卷,由 15 个项目组成,分为 8 个组,与 4 个功能域一致。
4 分或以上表示虚弱和可能出现精神错乱的风险较高。
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这是一项针对择期手术患者的观察性和前瞻性研究,因此不会给予任何干预。
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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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使用混淆评估方法 (CAM) 评分的混淆发生率
大体时间:手术后5天内
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如果存在以下情况,则存在谵妄: 特征 1-急性变化或/和波动(任何症状)和特征 2-注意力不集中以及特征 3-思维混乱或特征 4-意识水平改变 |
手术后5天内
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使用电话-蒙特利尔认知评估 (T-MOCA) 改变认知功能
大体时间:1个月内
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患者的认知功能将在出院后进行评估,并且必须在术后第 7 天通过电话使用 T-MOCA,随后在 1 个月和 3 个月后进行评估。
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1个月内
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使用 4AT 分数判断谵妄的发生
大体时间:手术后5天内
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4 分或以上表明精神错乱但不能诊断:可能需要对精神状态进行更详细的评估才能做出诊断。
1-3 分表明存在认知障碍,需要更详细的认知测试和线人病史采集。
0 分不能明确排除谵妄或认知障碍:根据临床情况,可能需要更详细的测试。
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手术后5天内
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合作者和调查者
调查人员
- 首席研究员:Pui San Loh、University Malaya
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.