NCT05742113

Brief Summary

Dyspnea is one of the most common reasons for admission to the emergency department\[1\]. Oxygen saturation has great importance in determining the triage status of patients admitted to the hospital with dyspnea and planning the emergency treatment \[2\]. Peripheral perfusion index (PI), which shows tissue oxygenation is a noninvasive way of demonstrating tissue perfusion in critically ill patients. Studies have shown that PI is an accurate, fast and reliable pulse oximetry-based indicator of tissue perfusion \[3-5\]. PI shows the perfusion status of the tissue in the applied area for an instant and a certain time interval. The PI value ranges from 0.02% (very weak) to 20% (strong) \[6\]. Triage scales are used to distinguish emergency and non-emergency patients. The emergency triage system is used to quickly determine the care priorities of patients during admission to the emergency department\[7,8\]. It is important to make the triage classification for dyspnea in emergency services quickly and accurately to start the treatment protocols as early as. In this study, the investigators aimed to determine the relationship between perfusion index and the emergency triage classification in patients admitted to the emergency department with dyspnea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,490

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

January 31, 2023

Last Update Submit

March 12, 2024

Conditions

Dyspnea

Keywords

DyspneaEmergencyPerfusion indexTriage

Outcome Measures

Primary Outcomes (3)

  • Perfusion index use for triage status

    for determination of triage status of patients with dyspnea with using perfusion index

    perfusion index measurement at the time of first admission to hospital

  • Perfusion index use for triage status

    for determination of triage status of patients with dyspnea with using perfusion index

    perfusion index measurement at the time of the first hour after admission to hospital

  • Perfusion index use for triage status

    for determination of triage status of patients with dyspnea with using perfusion index

    perfusion index measurement at the time of the second hour after admission to hospital

Study Arms (1)

Triage status red

EXPERIMENTAL

the relationship between the perfusion index and the emergency triage classification in patients admitted to the emergency department with dyspnea.

Device: Masimo Radical-7

Interventions

Masimo Radical-7DEVICE

perfusion index measuring device

Triage status red

Eligibility Criteria

Age18 Years - 96 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients over the age of 18 who presented with dyspnea
  • whose perfusion index values were measured at the time of first admission (arrival time), at the first hour and the second hour of admission were included in the study

You may not qualify if:

  • Patients who applied due to the mechanism of trauma,
  • patients with known vascular disease (Buerger's disease, peripheral artery disease, etc.), -patients with COVID-19 PCR positivity
  • whose perfusion index measurement could not be completed due to hospitalization or discharge were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Manisa, 45030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DyspneaEmergencies

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Cumhur M TULAY, Ass.Prof.

    Ass.Prof.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
no masking
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Aaa.Prof.

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 23, 2023

Study Start

January 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

The result will be explained in the manuscript when published.

Locations

TU(1)