search
Back to results

Emergency Classification According to Fingertip Circulation

Primary Purpose

Dyspnea

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Masimo Radical-7
Sponsored by
Manisa Celal Bayar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dyspnea focused on measuring Dyspnea, Emergency, Perfusion index, Triage

Eligibility Criteria

18 Years - 96 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Manisa Celal Bayar University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triage status red

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 31, 2023
Last Updated
April 18, 2023
Sponsor
Manisa Celal Bayar University
search

1. Study Identification

Unique Protocol Identification Number
NCT05742113
Brief Title
Emergency Classification According to Fingertip Circulation
Official Title
DYSPNEA: PERFUSION INDEX and TRIAGE STATUS (the Name of the Project)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manisa Celal Bayar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Purpose: To determine the effect of PI measurement on the emergency triage classification in patients with dyspnea. Methods: Adult patients who presented with dyspnea and whose perfusion index values were measured with Masimo Radical-7 device at the time of admission, at the first hour and the second hour of admission were included in the study. The PI and oxygen saturation measured by finger probes were compared and the superiority of their effects on the emergency triage classification was compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
Dyspnea, Emergency, Perfusion index, Triage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
no masking
Allocation
N/A
Enrollment
1490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triage status red
Arm Type
Experimental
Arm Description
the relationship between the perfusion index and the emergency triage classification in patients admitted to the emergency department with dyspnea.
Intervention Type
Device
Intervention Name(s)
Masimo Radical-7
Intervention Description
perfusion index measuring device
Primary Outcome Measure Information:
Title
Perfusion index use for triage status
Description
for determination of triage status of patients with dyspnea with using perfusion index
Time Frame
perfusion index measurement at the time of first admission to hospital
Title
Perfusion index use for triage status
Description
for determination of triage status of patients with dyspnea with using perfusion index
Time Frame
perfusion index measurement at the time of the first hour after admission to hospital
Title
Perfusion index use for triage status
Description
for determination of triage status of patients with dyspnea with using perfusion index
Time Frame
perfusion index measurement at the time of the second hour after admission to hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
96 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cumhur M TULAY, Ass.Prof.
Organizational Affiliation
Ass.Prof.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manisa Celal Bayar University
City
Manisa
ZIP/Postal Code
45030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The result will be explained in the manuscript when published.

Learn more about this trial

Emergency Classification According to Fingertip Circulation

We'll reach out to this number within 24 hrs