- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07824414
Prognostic Value of Pulse Oximetry Differences
Prognostic Significance of Multi-site Pulse Oximetry Differences in Dyspneic Emergency Department Patients
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This is a prospective observational cohort study conducted in a single ED to evaluate the prognostic significance of inter-site differences in pulse oximetry in adult patients presenting with dyspnea.
Adult patients (≥19 years) presenting with dyspnea and classified as Korean Triage and Acuity Scale (KTAS) levels 1-3 will be enrolled at the time of ED admission. During initial vital sign assessment at ED presentation, SpO₂ will be simultaneously measured at the finger, earlobe, and forehead, along with the corresponding perfusion index at each site.
The primary exposure of interest is the difference between finger and earlobe SpO₂ (ΔSpO₂). Additional inter-site SpO₂ differences involving forehead measurements will also be evaluated. Clinical and physiological data at presentation will be collected prospectively, while outcome data will be obtained through retrospective medical record review.
The primary outcome is the mean difference in ΔSpO₂ between patients with poor outcomes-defined as all-cause mortality from ED admission to hospital discharge or intensive care unit (ICU) admission-and those with favorable outcomes. Secondary outcomes include the associations of ΔSpO₂ with mortality, ICU admission, endotracheal intubation, serum lactate levels, and perfusion index, as well as the predictive performance of ΔSpO₂ using logistic regression and receiver operating characteristic (ROC) analysis. The prognostic value of ΔSpO₂ will also be compared with established early warning scores such as NEWS.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Stephen GW LEE, MD
- Telefonnummer: 82-10-5124-8415
- E-post: leestephengyungwon@yuhs.ac
Studiesteder
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Seoul
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Seoul, Seoul, Sør -Korea, 03722
- Rekruttering
- Yonsei University Severance Hospital
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Ta kontakt med:
- Stephen GW LEE, MD
- Telefonnummer: 82-2-2228-2678
- E-post: LEESTEPHENGYUNGWON@YUHS.AC
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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 19 years or older presenting to the emergency department with dyspnea, classified as KTAS level 1-3
Exclusion Criteria:
- Patients in whom SpO₂ measurements were not obtained simultaneously
- Patients in whom arterial blood gas analysis was not ordered at initial evaluation
- Pregnant patients
- Patients with facial trauma or hand trauma
- Patients with amputation, injury, or burns at the measurement sites
- Patients wearing nail polish
- Patients with dyshemoglobinemia
- Non-Korean nationality
- Patients who did not provide consent to participate in the study
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Dyspnea cohort
Patients visiting emergency department with dyspnea who are categorized to KTAS 1-3
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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In-hospital mortality or ICU admission
Tidsramme: From the index emergency department visit through hospital discharge, assessed up to 6 months.
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In-hospital mortality or ICU admission of index visit
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From the index emergency department visit through hospital discharge, assessed up to 6 months.
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 4-2025-1489
- 6-2025-0076 (Annet stipend/finansieringsnummer: Yonsei University College of Medicine)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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