DyspneaNCT07824414
Prognostic Value of Pulse Oximetry Differences
An observational study of Dyspnea, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyspnea
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 May 2026to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients aged 19 years or older presenting to the emergency department with dyspnea, classified as KTAS level 1-3
Who cannot join
- 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
Show all 9Show fewer
- Patients with dyshemoglobinemia
- Non-Korean nationality
- Patients who did not provide consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Severance Hospital
Seoul, Seoul, 03722
Stephen GW LEE, MD, 82-2-2228-2678, LEESTEPHENGYUNGWON@YUHS.AC
About this study
Official title: Prognostic Significance of Multi-site Pulse Oximetry Differences in Dyspneic Emergency Department Patients
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.
- Conditions
- Dyspnea
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dyspnea cohort | Patients visiting emergency department with dyspnea who are categorized to KTAS 1-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality or ICU admission
In-hospital mortality or ICU admission of index visit
Measured: From the index emergency department visit through hospital discharge, assessed up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start29 May 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE STEPHEN GYUNG WON, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824414
- Sponsor's protocol ID
- 4-2025-1489
- Other IDs
- 6-2025-0076
- Status last verified
- Sep 2026
- First submitted
- 30 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to concerns regarding patient privacy and personal information protection.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Multi-site Pulse Oximetry Differences in Dyspneic Emergency Department Patients
- ClinicalTrials.gov ID
- NCT07824414
- Acronym / sponsor ID
- 4-2025-1489
- Conditions
- Dyspnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 29 May 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dyspnea cohort | – | –Patients visiting emergency department with dyspnea who are categorized to KTAS 1-3 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients aged 19 years or older presenting to the emergency department with dyspnea, classified as KTAS level 1-3
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital mortality or ICU admission
Time frame: From the index emergency department visit through hospital discharge, assessed up to 6 months.
In-hospital mortality or ICU admission of index visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to concerns regarding patient privacy and personal information protection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen GW LEE, MD (82-10-5124-8415, leestephengyungwon@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality or ICU admission (time frame: From the index emergency department visit through hospital discharge, assessed up to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.