The Diagnostic Value of the First Clinical Impression of Patients Presenting to the Emergency Department (PREKEYDIA)

Sponsor
Kepler University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05597059
Collaborator
(none)
1,506
1
17.1
88.3

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Machine Learning Prediction

Study Design

Study Type:
Observational
Actual Enrollment :
1506 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Diagnostic Value of the First Clinical Impression of Patients Presenting to the Emergency Department
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Feb 28, 2020
Actual Study Completion Date :
Feb 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Shortness of breath

Diagnostic Test: Machine Learning Prediction
Machine Learning Prediction

Extremity pathologies

Diagnostic Test: Machine Learning Prediction
Machine Learning Prediction

Abdominal pain

Diagnostic Test: Machine Learning Prediction
Machine Learning Prediction

Urological pathologies

Diagnostic Test: Machine Learning Prediction
Machine Learning Prediction

Chest pain

Diagnostic Test: Machine Learning Prediction
Machine Learning Prediction

Back pain

Diagnostic Test: Machine Learning Prediction
Machine Learning Prediction

Outcome Measures

Primary Outcome Measures

  1. AUROC for Classification of Shortness of Breath [2019-09-01 to 2020-02-28]

    AUROC for Classification of Shortness of Breath

  2. AUROC for Classification of Extremity Pathologies [2019-09-01 to 2020-02-28]

    AUROC for Classification of Extremity Pathologies

  3. AUROC for Classification of Abdominal Pain [2019-09-01 to 2020-02-28]

    AUROC for Classification of Abdominal Pain

  4. AUROC for Classification of Urological Pathologies [2019-09-01 to 2020-02-28]

    AUROC for Classification of Urological Pathologies

  5. AUROC for Classification of Chest Pain [2019-09-01 to 2020-02-28]

    AUROC for Classification of Chest Pain

  6. AUROC for Classification of Back Pain [2019-09-01 to 2020-02-28]

    AUROC for Classification of Back Pain

Secondary Outcome Measures

  1. AUROC for Classification of Hospital Admission [2019-09-01 to 2020-02-28]

    AUROC for Classification of Hospital Admission

  2. Confusion Matrix [2019-09-01 to 2020-02-28]

    Confusion Matrix Results: true positives, true negatives, false positive, false negatives and values calculated from these results.

  3. Descriptive Statistics [2019-09-01 to 2020-02-28]

    Descriptive Statistics (e. g. age in years)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients presenting to the emergency department between 2019-09-01 and 2020-02-28.
Exclusion Criteria:
  • None.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kepler University Hospital Linz Upper Austria Austria 4021

Sponsors and Collaborators

  • Kepler University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kepler University Hospital
ClinicalTrials.gov Identifier:
NCT05597059
Other Study ID Numbers:
  • PREKEYDIA
First Posted:
Oct 27, 2022
Last Update Posted:
Oct 31, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2022