NCT07824414

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
May 2026Apr 2027

Study Start

First participant enrolled

May 29, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 30, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

May 30, 2026

Last Update Submit

September 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality or ICU admission

    In-hospital mortality or ICU admission of index visit

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

Study Arms (1)

Dyspnea cohort

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

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Severance Hospital

Seoul, Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

May 30, 2026

First Posted

September 17, 2026

Study Start

May 29, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to concerns regarding patient privacy and personal information protection.

Locations