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Prognostic Value of Pulse Oximetry Differences

Prognostic Significance of Multi-site Pulse Oximetry Differences in Dyspneic Emergency Department Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07824414
Enrollment
400
Registered
2026-09-17
Start date
2026-05-29
Completion date
2027-04-30
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea

Brief summary

This prospective observational study aims to evaluate whether the difference between finger, earlobe and forehead SpO₂ (ΔSpO₂) measured at emergency department (ED) presentation is associated with clinical outcomes in adult patients presenting with dyspnea. We will compare ΔSpO₂ between patients with poor outcomes (death or intensive care unit \[ICU\] admission) and those with favorable outcomes. Secondary objectives include assessing the prognostic value of ΔSpO₂ for mortality, ICU admission, and lactate, and comparing its predictive performance with established early warning scores.

Detailed description

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.

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
In-hospital mortality or ICU admissionFrom the index emergency department visit through hospital discharge, assessed up to 6 months.In-hospital mortality or ICU admission of index visit

Countries

South Korea

Contacts

CONTACTStephen GW LEE, MD
leestephengyungwon@yuhs.ac82-10-5124-8415

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026