Screening of Patients Admitted to a Local Hospital With Pocket-sized Ultrasound

Sponsor
Helse Nord-Trøndelag HF (Other)
Overall Status
Completed
CT.gov ID
NCT01081210
Collaborator
Norwegian University of Science and Technology (Other)
400
2
7
200
28.4

Study Details

Study Description

Brief Summary

Ultrasound (US) is widely used as a diagnostic tool in a hospital setting. In a medical department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia, hypovolemia, pleural effusion, pericardial effusion, ascites, diseases in the gall bladder/bile tract, urine tract and venous thrombosis are common. US is the key diagnostic tool in these diagnosis, and on early diagnosis is crucial both on behalf of the patients well-being, and for hospital logistic reasons.

  1. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool in an department of internal medicine.

Method: All patients admitted (in certain preset periods) to Department of medicine will be screened with pocket sized US by expert user. Changes in diagnoses, as well as medications as a result of US screening will be the endpoints. US findings will be validated against standard echocardiography, or standard US/CT/MRI performed at the Radiological department.

  1. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool in a department of cardiology.

Method: All patients admitted (in certain preset periods) to Department of cardiology will be screened with pocket sized US for heart disease, pericardial and pleural effusion. Examinations by expert users. Specific findings could be myocardial dysfunction as heart failure, cardiomyopathies, regional dysfunction due to ischemia, valvular dysfunction, atrial enlargement, and pleural/pericardial effusion. Changes in diagnoses, as well as medications as a result of US screening will be the endpoints. US findings will be validated against standard echocardiography in all.

  1. As in 1), but examination by non-expert users compared to expert users.
Condition or Disease Intervention/Treatment Phase
  • Other: Ultrasound examination

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Screening With Pocket-sized Ultrasound of Patients Admitted to Department of Medicine at a Local Hospital
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Ultrasound screening

Patients admitted to Department of medicine at local hospital. Randomized inclusion, informed consent obtained.

Other: Ultrasound examination
Screening with bedside ultrasound examination
Other Names:
  • GE Vingmed VScan
  • Outcome Measures

    Primary Outcome Measures

    1. Diagnostic sensitivity and specificity [After 3-6 months]

      Diagnostic accuracy and clinical usefulness of ultrasound screening as add on examination. Change in working diagnosis after ultrasound examination will be tested, and gold standards (echocardiography and examinations at Department of radiology) will be used for testing of sensitivity and specificity.

    Secondary Outcome Measures

    1. Non-experts [After 3-6 months]

      Validation of results from ultrasound examination made by non-experts compared to expert users.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 110 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients admitted to Dep. of Medicine at Levanger Hospital
    Exclusion Criteria:
    • Not able to give informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust Levanger Norway 7600
    2 Levanger Hospital, Department of Medicine Levanger Norway N-7600

    Sponsors and Collaborators

    • Helse Nord-Trøndelag HF
    • Norwegian University of Science and Technology

    Investigators

    • Principal Investigator: Havard Dalen, MD, Nord-Trøndelag Health Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Helse Nord-Trøndelag HF
    ClinicalTrials.gov Identifier:
    NCT01081210
    Other Study ID Numbers:
    • LH-2010-1
    • HD_2009_LU13
    First Posted:
    Mar 5, 2010
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Helse Nord-Trøndelag HF
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2021