- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07771608
Respiratory Admittance by Oscillometry in Children (ArsEIB)
Respiratory Admittance Response to Exercise Challenge Test in Children
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Iulia Ioan, MD PhD
- 전화번호: +33 3 83 15 47 94
- 이메일: ic.ioan@chru-nancy.fr
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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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)
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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)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic performance of Ars
기간: 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
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Through study completion, an average of 1 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sensitivity of Ars
기간: 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
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Through study completion, an average of 1 month
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Specificity of Ars
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Farre R. Measuring intra-subject changes in respiratory mechanics by oscillometry: impedance versus admittance. Eur Respir J. 2022 Oct 6;60(4):2201198. doi: 10.1183/13993003.01198-2022. Print 2022 Oct. No abstract available.
- Nguyen YT, Demoulin B, Schweitzer C, Bonabel-Chone C, Marchal F. Identification of bronchodilator responsiveness by forced oscillation admittance in children. Pediatr Res. 2007 Sep;62(3):348-52. doi: 10.1203/PDR.0b013e3180db2933.
- Ioan I, Coutier L, Bonabel C, Albrecht J, Demoulin B, Marchal F, Schweitzer C, Varechova S. Airway obstruction, upper airway artifact and response to bronchodilator in asthmatic and healthy children. Pediatr Pulmonol. 2015 Nov;50(11):1053-9. doi: 10.1002/ppul.23131. Epub 2014 Nov 10.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .