Emergency Classification According to Fingertip Circulation | NCT05742113

Studies
Emergency Classification According to Fingertip Circulation

NCT05742113

Sponsor

Manisa Celal Bayar University

Status

Completed

Last Update Posted

Mar 15, 2024Actual

Enrollment

1,490Actual

Phase

Not Applicable

Conditions

Dyspnea

Interventions

Masimo Radical-7

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Manisa Celal Bayar University	Other Identifier	2018-213

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Jan 31, 2023

First Submission Date that Met QC Criteria

Feb 21, 2023

First Posted Date

Feb 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2024

Last Update Posted Date

Mar 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cumhur Murat TULAY, Aaa.Prof., Manisa Celal Bayar UniversityPrincipal Investigator

Lead Sponsor

Manisa Celal Bayar UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,490Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Masimo Radical-7	Device	perfusion index measuring device	Triage status red

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

96 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cumhur M TULAY, Ass.Prof.	Ass.Prof.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Manisa Celal Bayar University		Manisa		45030	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

The result will be explained in the manuscript when published.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004417	Dyspnea
D004630	Emergencies

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

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Browse Branches

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