DyspneaNCT05742113
Emergency Classification According to Fingertip Circulation
A study testing Masimo Radical-7 in people with Dyspnea, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 to 96 years
- Conditions the study is for
- Dyspnea
- What is being tested?
- Masimo Radical-7
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,490 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 96 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DYSPNEA: PERFUSION INDEX and TRIAGE STATUS (the Name of the Project)
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].
Read more
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.
Read the 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.
- Conditions
- Dyspnea
- Being tested
- Masimo Radical-7
- Keywords
- Dyspnea, Emergency, Perfusion index, Triage
- Medical subject headings
- Dyspnea, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Radical-7Device
perfusion index measuring device
| Study group | Role | What they receive |
|---|---|---|
| Triage status red | Experimental | the relationship between the perfusion index and the emergency triage classification in patients admitted to the emergency department with dyspnea. Receives: Device: Masimo Radical-7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion index use for triage status
for determination of triage status of patients with dyspnea with using perfusion index
Measured: 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
Measured: 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
Measured: perfusion index measurement at the time of the second hour after admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Jan 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cumhur Murat TULAY, Manisa Celal Bayar University
- Investigators
- Cumhur M TULAY, Ass.Prof., Principal investigator, Ass.Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742113
- Sponsor's protocol ID
- 10.10.2018 and 20.478.486
- Other IDs
- Manisa Celal Bayar University
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The result will be explained in the manuscript when published.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DYSPNEA: PERFUSION INDEX and TRIAGE STATUS (the Name of the Project)
- ClinicalTrials.gov ID
- NCT05742113
- Acronym / sponsor ID
- 10.10.2018 and 20.478.486
- Conditions
- Dyspnea
- Keywords
- Dyspnea, Emergency, Perfusion index, Triage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,490 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triage status red | Experimental | Device: Masimo Radical-7the relationship between the perfusion index and the emergency triage classification in patients admitted to the emergency department with dyspnea. |
Who may qualify
- Ages
- 18 to 96 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masimo Radical-7perfusion index measuring device | Device | Triage status red |
Primary outcome
Perfusion index use for triage status
Time frame: perfusion index measurement at the time of first admission to hospital
for determination of triage status of patients with dyspnea with using perfusion index
Perfusion index use for triage status
Time frame: perfusion index measurement at the time of the first hour after admission to hospital
for determination of triage status of patients with dyspnea with using perfusion index
Perfusion index use for triage status
Time frame: perfusion index measurement at the time of the second hour after admission to hospital
for determination of triage status of patients with dyspnea with using perfusion index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No. The result will be explained in the manuscript when published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cumhur M TULAY, Ass.Prof. principal investigator
Ass.Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Masimo Radical-7 in people with Dyspnea, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion index use for triage status (time frame: perfusion index measurement at the time of first admission to hospital). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.