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临床试验/NCT07824414
NCT07824414招募中不适用

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

Yonsei University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
In-hospital mortality or ICU admission

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Dyspnea cohort

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

结局指标

主要结局

In-hospital mortality or ICU admission

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

In-hospital mortality or ICU admission of index visit

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

LEE STEPHEN GYUNG WON

Clinical assistant professor

Yonsei University

研究点 (1)

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