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

This study has been completed.
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by:
Levanger Hospital
ClinicalTrials.gov Identifier:
NCT01081210
First received: February 25, 2010
Last updated: March 29, 2011
Last verified: February 2010
History of Changes
  Purpose

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.

  2. 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.

  3. As in 1), but examination by non-expert users compared to expert users.

Condition Intervention
Heart Disease
Dyspnea
Aortic Disease
Kidney Disease
Liver Disease
 Other: Ultrasound examination

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Screening With Pocket-sized Ultrasound of Patients Admitted to Department of Medicine at a Local Hospital

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Levanger Hospital:

Primary Outcome Measures:
  • Diagnostic sensitivity and specificity [ Time Frame: After 3-6 months ] [ Designated as safety issue: No ]
    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:
  • Non-experts [ Time Frame: After 3-6 months ] [ Designated as safety issue: No ]
    Validation of results from ultrasound examination made by non-experts compared to expert users.


Biospecimen Retention:   Samples Without DNA

Serum blood samples including; hematology, electrolytes, creatinine, liver enzymes and cholestasis parametres, brain natriuretic peptides etc.


Estimated Enrollment: 400
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: GE Vingmed VScan

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients admitted to Dep. of Medicine at Levanger Hospital Randomized study. Both sexes. Age above 16 years

Criteria

Inclusion Criteria:

  • Patients admitted to Dep. of Medicine at Levanger Hospital

Exclusion Criteria:

  • Not able to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081210

Locations
Norway
Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust
Levanger, Norway, 7600
Levanger Hospital, Department of Medicine
Levanger, Norway, N-7600
Sponsors and Collaborators
Levanger Hospital
Norwegian University of Science and Technology
Investigators
Principal Investigator: Havard Dalen, MD Nord-Trøndelag Health Trust
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Havard Dalen, MD, Consultant, Department of Medicine, Nord-Trøndelag Health Trust
ClinicalTrials.gov Identifier: NCT01081210     History of Changes
Other Study ID Numbers: LH-2010-1, HD_2009_LU13
Study First Received: February 25, 2010
Last Updated: March 29, 2011
Health Authority: Norway: Ethics Committee

Keywords provided by Levanger Hospital:
Echocardiography
Heart failure
Kidney
Lung
Aorta

Additional relevant MeSH terms:
Aortic Diseases
Dyspnea
Heart Diseases
Kidney Diseases
Liver Diseases
Vascular Diseases
Cardiovascular Diseases
 Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Urologic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013