EmergenciesNCT05597059
The Diagnostic Value of the First Clinical Impression of Patients Presenting to the Emergency Department (PREKEYDIA)
An observational study of Emergencies, run by Kepler University Hospital at 1 site in Austria.
Trial summary
Finding a diagnosis for acutely ill patients places high demands on emergency medical personnel. While anamnesis and clinical examination provide initial indications and allow a tentative diagnosis, both laboratory chemistry and imaging tests are used to confirm (or exclude) the tentative diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergencies
- What is being tested?
- Machine Learning Prediction
- How many people
- 1,506 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2019to 1 Feb 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults presenting to the emergency department.
Who may be able to join
- Patients presenting to the emergency department between 2019-09-01 and 2020-02-28.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Diagnostic Value of the First Clinical Impression of Patients Presenting to the Emergency Department
Finding a diagnosis for acutely ill patients places high demands on emergency medical personnel. While anamnesis and clinical examination provide initial indications and allow a tentative diagnosis, both laboratory chemistry and imaging tests are used to confirm (or exclude) the tentative diagnosis. The more precise and targeted the additional laboratory chemical or radiological diagnosis, the more quickly and economically the causal treatment of the emergency patient can be initiated.
One examination modality, which in addition to the medical history and clinical examination, could quickly provide information about the condition of the patient, their clinical picture and severity of illness, is the first clinical impression of the patient (so-called "first impression" or "end-of-bed view"). This describes the first sensory impression that the medical staff gathers from a patient. This includes visual (e.g., facial expression, gait, breathing), auditory (e.g., voice pitch, shortness of breath when speaking), and olfactory (e.g., smell of exhaled air, body odor) impressions. Clinical practice shows that a great deal of important additional information can be gathered through this first clinical impression, which, together with the history and clinical examination of the emergency patient, provides valuable clues to the underlying condition.
To date, however, only scattered data and study results exist in the medical literature on the value of the first clinical impression in the care of emergency patients. In the present prospective observational study, the study attempts to evaluate the predictive value of the first clinical impression in identifying a leading symptom and other important clinical parameters.
- Conditions
- Emergencies
- Being tested
- Machine Learning Prediction
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine Learning PredictionDiagnostic test
Machine Learning Prediction
| Study group | Role | What they receive |
|---|---|---|
| Shortness of breath | Not described Receives: Diagnostic Test: Machine Learning Prediction | |
| Extremity pathologies | Not described Receives: Diagnostic Test: Machine Learning Prediction | |
| Abdominal pain | Not described Receives: Diagnostic Test: Machine Learning Prediction | |
| Urological pathologies | Not described Receives: Diagnostic Test: Machine Learning Prediction | |
| Chest pain | Not described Receives: Diagnostic Test: Machine Learning Prediction | |
| Back pain | Not described Receives: Diagnostic Test: Machine Learning Prediction |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUROC for Classification of Shortness of Breath
AUROC for Classification of Shortness of Breath
Measured: 2019-09-01 to 2020-02-28
AUROC for Classification of Extremity Pathologies
AUROC for Classification of Extremity Pathologies
Measured: 2019-09-01 to 2020-02-28
AUROC for Classification of Abdominal Pain
AUROC for Classification of Abdominal Pain
Measured: 2019-09-01 to 2020-02-28
AUROC for Classification of Urological Pathologies
AUROC for Classification of Urological Pathologies
Measured: 2019-09-01 to 2020-02-28
AUROC for Classification of Chest Pain
AUROC for Classification of Chest Pain
Measured: 2019-09-01 to 2020-02-28
AUROC for Classification of Back Pain
AUROC for Classification of Back Pain
Measured: 2019-09-01 to 2020-02-28
Secondary outcomes (3)
AUROC for Classification of Hospital Admission
AUROC for Classification of Hospital Admission
Measured: 2019-09-01 to 2020-02-28
Confusion Matrix
Confusion Matrix Results: true positives, true negatives, false positive, false negatives and values calculated from these results.
Measured: 2019-09-01 to 2020-02-28
Descriptive Statistics
Descriptive Statistics (e. g. age in years)
Measured: 2019-09-01 to 2020-02-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Sep 2019
- Primary completion28 Feb 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597059
- Sponsor's protocol ID
- PREKEYDIA
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of the First Clinical Impression of Patients Presenting to the Emergency Department
- ClinicalTrials.gov ID
- NCT05597059
- Acronym / sponsor ID
- PREKEYDIA
- Conditions
- Emergencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,506 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 27 Oct 2022 (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.
Finding a diagnosis for acutely ill patients places high demands on emergency medical personnel. While anamnesis and clinical examination provide initial indications and allow a tentative diagnosis, both laboratory chemistry and imaging tests are used to confirm (or exclude) the tentative diagnosis. The more precise and targeted the additional laboratory chemical or radiological diagnosis, the more quickly and economically the causal treatment of the emergency patient can be initiated.
One examination modality, which in addition to the medical history and clinical examination, could quickly provide information about the condition of the patient, their clinical picture and severity of illness, is the first clinical impression of the patient (so-called "first impression" or "end-of-bed view"). This describes the first sensory impression that the medical staff gathers from a patient. This includes visual (e.g., facial expression, gait, breathing), auditory (e.g., voice pitch, shortness of breath when speaking), and olfactory (e.g., smell of exhaled air, body odor) impressions. Clinical practice shows that a great deal of important additional information can be gathered through this first clinical impression, which, together with the history and clinical examination of the emergency patient, provides valuable clues to the underlying condition.
To date, however, only scattered data and study results exist in the medical literature on the value of the first clinical impression in the care of emergency patients. In the present prospective observational study, the study attempts to evaluate the predictive value of the first clinical impression in identifying a leading symptom and other important clinical parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Shortness of breath | – | Diagnostic Test: Machine Learning Prediction |
| Extremity pathologies | – | Diagnostic Test: Machine Learning Prediction |
| Abdominal pain | – | Diagnostic Test: Machine Learning Prediction |
| Urological pathologies | – | Diagnostic Test: Machine Learning Prediction |
| Chest pain | – | Diagnostic Test: Machine Learning Prediction |
| Back pain | – | Diagnostic Test: Machine Learning Prediction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults presenting to the emergency department.
Key inclusion criteria (1 listed)
- Patients presenting to the emergency department between 2019-09-01 and 2020-02-28.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Machine Learning PredictionMachine Learning Prediction | Diagnostic test | Abdominal pain, Back pain, Chest pain, Extremity pathologies, Shortness of breath, Urological pathologies |
Primary outcome
AUROC for Classification of Shortness of Breath
Time frame: 2019-09-01 to 2020-02-28
AUROC for Classification of Shortness of Breath
AUROC for Classification of Extremity Pathologies
Time frame: 2019-09-01 to 2020-02-28
AUROC for Classification of Extremity Pathologies
AUROC for Classification of Abdominal Pain
Time frame: 2019-09-01 to 2020-02-28
AUROC for Classification of Abdominal Pain
AUROC for Classification of Urological Pathologies
Time frame: 2019-09-01 to 2020-02-28
AUROC for Classification of Urological Pathologies
AUROC for Classification of Chest Pain
Time frame: 2019-09-01 to 2020-02-28
AUROC for Classification of Chest Pain
AUROC for Classification of Back Pain
Time frame: 2019-09-01 to 2020-02-28
AUROC for Classification of Back Pain
3 secondary outcomes
AUROC for Classification of Hospital Admission
Time frame: 2019-09-01 to 2020-02-28
Confusion Matrix
Time frame: 2019-09-01 to 2020-02-28
Descriptive Statistics
Time frame: 2019-09-01 to 2020-02-28
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 31 Oct 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies, run by Kepler University Hospital at 1 site in Austria.
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 1 inclusion and 1 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 31 Oct 2022. 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 Austria. 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?
AUROC for Classification of Shortness of Breath (time frame: 2019-09-01 to 2020-02-28). The study lists 6 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 31 Oct 2022.