- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07658131
External Validation of AI-Aided Weaning Software Using Multicenter Retrospective Data
Using Multicenter Retrospective Data to Validate the Performance of AI-Aided Weaning Software
Studieoversikt
Status
Detaljert beskrivelse
Critical care generates a large amount of digitized clinical data that may benefit from artificial intelligence-assisted decision support. The AI-Aided Weaning Software was previously developed using ICU data from Taichung Veterans General Hospital collected between 2015 and 2019.
This retrospective multicenter validation study will evaluate the external performance of the established model using independent datasets from four hospitals in Taiwan, including Taichung Veterans General Hospital, Mackay Memorial Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, and Tungs' Taichung MetroHarbor Hospital.
The study population includes adult ICU patients with respiratory failure who received mechanical ventilation for at least 72 hours between January 2020 and December 2024. De-identified routine clinical records will be collected according to a predefined case report form and analyzed centrally.
The primary objective is to assess the external validity of the AI-Aided Weaning Software across different hospitals. Model performance will be evaluated using sensitivity, specificity, accuracy, AUROC, and F1 score.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Taichung, Taiwan
- Taichung Veterans General Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Adult patients aged 20 years or older.
- Admitted to the intensive care unit (ICU) at one of the participating hospitals between January 1, 2020 and December 31, 2024.
- Received invasive mechanical ventilation for at least 72 hours.
- Availability of de-identified clinical data required for model validation.
Exclusion Criteria:
- Patients who did not receive invasive mechanical ventilation.
- Duration of mechanical ventilation less than 72 hours.
- Missing key clinical variables required for model validation.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Mechanically Ventilated ICU Patients
Adult intensive care unit patients aged 20 years or older who received invasive mechanical ventilation for at least 72 hours between January 2020 and December 2024 at four participating hospitals.
Retrospective de-identified clinical data were used to validate the performance of AI-Aided Weaning Software.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Model Performance (AUROC)
Tidsramme: Using data collected during ICU admission
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Area under the receiver operating characteristic curve (AUROC) for predicting successful extubation.
AUROC ranges from 0.5 to 1.0, with higher values indicating better discriminative performance of the prediction model.
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Using data collected during ICU admission
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sensitivity
Tidsramme: ICU admission
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SensitivitySensitivity of the prediction model for successful extubation.
Sensitivity ranges from 0 to 1 (or 0% to 100%), with higher values indicating better identification of patients who achieve successful extubation.
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ICU admission
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Specificity
Tidsramme: ICU admission
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Specificity of the prediction model for successful extubation.
Specificity ranges from 0 to 1 (or 0% to 100%), with higher values indicating better identification of patients who do not achieve successful extubation.
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ICU admission
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Accuracy
Tidsramme: ICU admission
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Accuracy of the prediction model for successful extubation.
Accuracy ranges from 0 to 1 (or 0% to 100%), with higher values indicating better overall prediction performance.
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ICU admission
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F1 Score
Tidsramme: ICU admission
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F1 score of the prediction model for successful extubation.
F1 score ranges from 0 to 1, with higher values indicating better balance between precision and recall.
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ICU admission
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TCVGH-AI-WEAN-2026
- TCVGH-AI-Weaning-2026 (Annen identifikator: Taichung Veterans General Hospital)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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