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Respiratory Admittance by Oscillometry in Children (ArsEIB)

2026年8月17日 更新者:Dr. Iulia IOAN、Central Hospital, Nancy, France

Respiratory Admittance Response to Exercise Challenge Test in Children

Oscillometry is a pulmonary function testing technique suited for children because it does not require specific respiratory maneuvers like spirometry. Oscillometry provides a measure of respiratory impedance (Zrs) that is underestimated when the oscillatory signal is applied at the subject's mouth particularly during bronchoconstriction induced by an exercise challenge test (ECT). This limitation may be overcome by calculating respiratory admittance (Ars), the inverse of respiratory impedance during an ECT.

研究概览

地位

尚未招聘

详细说明

Oscillometry is a pulmonary function testing technique that is well suited to children who have difficulty cooperating with conventional tests such as spirometry, as it is performed during spontaneous breathing and does not require specific respiratory maneuvers. In contrast, spirometry requires a deep inspiration followed by a forced and complete expiration.

Oscillometry provides a measure of respiratory impedance, which is the complex sum of respiratory resistance (Rrs) and respiratory reactance (Xrs). However, when the oscillatory signal is applied directly at the subject's airway opening, part of the flow signal may be lost due to cheek wall vibrations, resulting in an underestimation of Rrs. This underestimation may be more pronounced during bronchoconstriction, such as that induced by an exercise challenge test (ECT). This limitation may be overcome by calculating respiratory admittance (Ars), the inverse of respiratory impedance. When calculating the response to ECT, cheek wall admittance is cancelled out, potentially allowing a more accurate assessment of changes in respiratory mechanics during an ECT.

The hypothesis was that calculating Ars provides a more accurate assessment of changes in airway mechanics during an ECT.

研究类型

观察性的

注册 (估计的)

144

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

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

  • 孩子

接受健康志愿者

不

取样方法

非概率样本

研究人群

Data of children aged 5 to 16 years addressed by the pediatric pulmonologist to an exercise challenge test between January 2023 and April 2026 to the Pediatric Function Testing Department who have oscillometric and spirometric interpretable and reproducible measurements

描述

Inclusion Criteria:

  • Children aged 5 to 16 years
  • Children addressed by the pediatric pulmonologist to an exercise challenge test between January 2023 and April 2026
  • Children with interpretable and reproducible oscillometric measurements
  • Children with interpretable and reproducible spirometric measurements

Exclusion Criteria:

  • Children who performed only spirometric measurements
  • Children who performed only oscillometric measurements
  • Children whose oscillometric and spirometric measurements are non-interpretable
  • Children whose oscillometric and spirometric measurements are non-reproducible

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
Children with positive response to exercise challenge test
Children aged 5 to 16 years old who performed an exercise challenge test and had a decrease of ≥ 10% in FEV1 after test (FEV1 = forced expiratory volume in 1 sec obtained by forced spirometry)
Children with NEGATIVEresponse to exercise challenge test
Children aged 5 to 16 years old who performed an exercise challenge test and had a decrease of < 10% in FEV1 after test (FEV1 = forced expiratory volume in 1 sec obtained by forced spirometry)

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
Diagnostic performance of Ars
大体时间:Through study completion, an average of 1 month
Area under the ROC curves (AUC) for response to exercise challenge of Ars (computed from oscillometric parameters) compared with AUC of respiratory resistance to identify children with a positive challenge test and children with a negative challenge test
Through study completion, an average of 1 month

次要结果测量

结果测量
措施说明
大体时间
Sensitivity of Ars
大体时间:Through study completion, an average of 1 month
Sensitivity of the response to exercise challenge of Ars (computed from oscillometric parameters) compared with the sensitivity of respiratory resistance to identify children with a positive challenge test
Through study completion, an average of 1 month
Specificity of Ars
大体时间:Through study completion, an average of 1 month
Specificity of the response to exercise challenge of Ars (computed from oscillometric parameters) compared with the specificity of respiratory resistance to identify children with a positive challenge test
Through study completion, an average of 1 month

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。

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 (估计的)

2026年8月25日

初级完成 (估计的)

2026年8月25日

研究完成 (估计的)

2026年9月1日

研究注册日期

首次提交

2026年8月12日

首先提交符合 QC 标准的

2026年8月15日

首次发布 (实际的)

2026年8月18日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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