- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07771608
Respiratory Admittance by Oscillometry in Children (ArsEIB)
Respiratory Admittance Response to Exercise Challenge Test in Children
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Iulia Ioan, MD PhD
- Telefonnummer: +33 3 83 15 47 94
- E-post: ic.ioan@chru-nancy.fr
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic performance of Ars
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sensitivity of Ars
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026PI185
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