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RecruitingNCT07824414Updated Sep 17, 2026

Prognostic Value of Pulse Oximetry Differences

An observational study in Dyspnea, sponsored by Yonsei University. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Yonsei University · Observational

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dyspnea

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03

In context

Dyspnea

894 studies on the registry are indexed under Dyspnea; 189 are open to participants now.

This study's planned enrollment of 400 is above the median of 106 across 272 observational studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

We will enroll patients who meet the enrollment criteria who visit an emergency department of a tertiary teaching hospital located in Seoul, South Korea.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients aged 19 years or older presenting to the emergency department with dyspnea, classified as KTAS level 1-3

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Dyspnea cohort

    Patients visiting emergency department with dyspnea who are categorized to KTAS 1-3

06

What researchers measure

Primary outcomes

  1. In-hospital mortality or ICU admission

    In-hospital mortality or ICU admission of index visit

    Time frame: From the index emergency department visit through hospital discharge, assessed up to 6 months.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to concerns regarding patient privacy and personal information protection.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Mar 2027, 10 months after the start.

Of 116 non-industry observational studies under Dyspnea, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 10 months is below that.

Counting every sponsor, half of 125 studies reached it within 24 months; a quarter within 11 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2026
First posted
Sep 17, 2026
StartActual
May 29, 2026
Primary completionEst.
Mar 31, 2027
CompletionEst.
Apr 30, 2027
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07824414
Lead sponsor
Yonsei University
Responsible party
LEE STEPHEN GYUNG WON (Clinical assistant professor, Yonsei University) — Principal investigator
First posted
Sep 17, 2026
Start date
May 29, 2026
Primary completion
Mar 31, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Stephen GW LEE, MD
Contact
leestephengyungwon@yuhs.ac
82-10-5124-8415

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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