肺部超声评分和儿科重症监护结果 (LUS-PICO) (LUS-PICO)
肺部超声评分和儿科重症监护结果:一项前瞻性观察性多中心研究
研究概览
详细说明
肺通气可以在床边通过肺部超声进行评估,这是一种非侵入性、快速、简单且可重复的技术。 它提供有关血管外肺水 (EVLW) 量的半定量信息,这与肺通气相关。 EVLW 的积累继发于感染、炎症或液体超负荷引起的急性肺损伤。 通过肺部超声评分 (LUS) 测量的肺通气在几项针对成年患者的研究中与患者的结果相关,这表明表现出更高程度通气损失的危重患者的结果更差。 这一事实不仅在患有基线呼吸系统疾病(例如严重急性呼吸系统综合症冠状病毒 2)的患者中得到证实,而且在患有非呼吸系统疾病(例如休克)和高危术后患者中也得到证实。 此外,动物研究表明,通过肺部超声检查获得的信息可能先于临床症状,并有助于预测重点治疗。
迄今为止,解决 LUS 与危重儿童预后之间潜在关系的儿科研究很少,而且仅限于术后心脏病患者和患有毛细支气管炎的婴儿。
在我们的研究中,将招募符合纳入标准的 1 个月至 18 岁入住儿科重症监护病房 (PICU) 的儿童,并将在出生后 12 ± 6 小时和出生后 48-72 小时进行床旁肺部超声检查录取。 将记录临床数据并计算 LUS。 我们研究的主要目的是评估 LUS(作为半定量指标或肺通气)作为 PICU 收治儿童的可行且可靠的结果预测工具的潜在作用。 次要目标将包括分析 LUS 与通气支持的需要和持续时间、炎症和心脏标志物、水分平衡、肾脏替代疗法要求和经过验证的预后量表以及年龄、潜在疾病、合并症、持续时间之间的相关性--of-stay,以及包括儿童的其他临床特征。
在 PICU 入院期间患有急性呼吸窘迫综合征 (ARDS) 或休克的患者还将在 ARDS 或休克诊断后 12 ± 6 小时和 48-72 小时进行额外的肺部超声检查,因为这些亚组代表了非常特殊和严重的队列患者,值得进一步分析。
研究类型
注册 (实际的)
联系人和位置
学习地点
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Principado De Asturias
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Oviedo、Principado De Asturias、西班牙、33011
- Hospital Universitario Central de Asturias (HUCA)
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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:
- 因急性病症入住 PICU 的 1 个月至 18 岁儿童
排除标准:
- - 儿童进入 PICU 执行手术或调整某种治疗(例如,家庭通气支持)。
- - 患有慢性肺病的儿童(囊性纤维化、支气管肺发育不良等……)
- - 术前入院情况稳定(例如 患者之前接受过心脏手术)
- - 由于超声窗口不良,无法获得可解释的超声图像
- - 调查员不负责任
- - 高频通气
- - 缺乏临床数据
学习计划
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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要求有创机械通气96小时以上
大体时间:96小时
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评估入院后 72 小时内获得的 LUS 与需要有创通气支持超过 96 小时的相关性。
将对入院原因为呼吸系统疾病和非呼吸系统疾病的患者进行比较。
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96小时
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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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肺通气与床旁炎症标志物的相关性
大体时间:72小时
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评估 LUS 估计的肺通气与床旁炎症标志物(C 反应蛋白、白细胞介素 6、降钙素原、铁蛋白)之间的关系
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72小时
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肺通气与床旁心脏标志物的相关性
大体时间:72小时
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评估 LUS 估计的肺通气与床旁心脏标志物(脑利钠肽、N-末端 proBNP、肌钙蛋白、胱抑素 C)之间的关系
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72小时
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肺通气和水分平衡与肾脏替代治疗需求的相关性
大体时间:72小时
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评估 LUS 估计的肺通气与水平衡和肾脏替代治疗需求之间的关系
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72小时
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LUS与儿科死亡率量表之间的相关性
大体时间:72小时
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评估肺通气与三个预后指标之间的关系:儿科死亡风险(PRISM)III、儿科序贯器官衰竭评估(pSOFA)、儿科逻辑器官功能障碍 2(PELOD-2)。
还将评估 LUS 是否可以为这些量表增加任何预后能力。
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72小时
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探索 12 个区域与 8 个区域的 LUS 计算比较
大体时间:72小时
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比较使用 12 个肺区计算的 LUS 与使用 8 个区域(仅前侧和外侧区域)获得的 LUS 的预后能力
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72小时
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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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LUS 在入院 24 小时后诊断为急性呼吸窘迫综合征 (ARDS) 的患者中的效用
大体时间:72小时
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所有先前指定的目标都将在诊断为 ARDS 的儿童中进行评估。
在这些情况下,LUS 将在 ARDS 诊断后 12 +/- 6 小时和 72 小时计算。
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72小时
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LUS 在入院 24 小时后诊断为休克的患者中的效用
大体时间:72小时
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将在入院 24 小时后诊断为休克的儿童中评估所有先前指定的目标。
在这些情况下,LUS 将在休克诊断后 12 +/- 6 小时和 72 小时计算。
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72小时
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合作者和调查者
调查人员
- 学习椅:Guillermo M. Albaiceta, MD PhD、HUCA-FINBA. Universidad de Oviedo
- 首席研究员:Juan Mayordomo-Colunga, MD PhD、HUCA-FIBA
出版物和有用的链接
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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
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