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临床试验/NCT07771608
NCT07771608尚未招募不适用

Respiratory Admittance Response to Exercise Challenge Test in Children

Central Hospital, Nancy, France0 个研究点目标入组 144 人开始时间: 2026年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
144
主要终点
Diagnostic performance of Ars

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
5 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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)

结局指标

主要结局

Diagnostic performance of Ars

时间窗: 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

次要结局

  • Sensitivity of Ars(Through study completion, an average of 1 month)
  • Specificity of Ars(Through study completion, an average of 1 month)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Iulia IOAN

Head of Pediatric Function Testing Department

Central Hospital, Nancy, France

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