Influence of Routinely Adding Ultrasound Screening in Medical Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01331187
Recruitment Status : Completed
First Posted : April 7, 2011
Last Update Posted : June 1, 2012
Norwegian University of Science and Technology
Information provided by:
Levanger Hospital

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 with respect to the patients well-being and inpatients workflow.

1. The aim is to study the clinical use of pocket-size US as a screening diagnostic tool in an medical department with respect to inpatients workflow and diagnostics.

Method: Patients admitted (in certain preset periods) to Department of medicine will be randomized to routinely adding an ultrasound examination with pocket-size device by residents on call. Time to definitive diagnosis, time to definitive treatment and time to discard will be recorded. US findings will be validated against standard echocardiography, or standard US/CT/MRI performed at the Radiological department.

Condition or disease Intervention/treatment Phase
Heart Disease Dyspnea Aortic Disease Kidney Disease Liver Disease Procedure: Pocket-size ultrasonography Other: Usual care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence on Diagnostics and Inpatient Workflow of Routinely Adding Ultrasound Screening by Pocket-size Ultrasound in a Medical Department
Study Start Date : April 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Usual care
Usual care diagnostics. No routinely ultrasound examination
Other: Usual care
No intervention, except for usual care (goal-directed diagnostics)

Experimental: Routinely ulasonography
Patients will routinely be examined with ultrasound at admittance in addition to usual care diagnostics
Procedure: Pocket-size ultrasonography
Routinely adding a ultrasound examination of the heart, pleura, great abdominal vessels, liver/gall bladder and kidneys at patients admittance to hospital

Primary Outcome Measures :
  1. Time to definitive diagnosis [ Time Frame: 3 months ]
    Time from admittance to definitive diagnosis

Secondary Outcome Measures :
  1. Test-retest reproducibility [ Time Frame: 3 months ]
    Pocket-sized ultrasound recordings by residents will be validated against reference methods (echocardiography and radiologic examinations by sepcialists)to assess sensitivity, specificity, positive and negative predictive values of pocket-size ultrasound.

  2. Diagnostic outcome of additional ultrasound examination according to educational level of the performer [ Time Frame: 3 months ]
    Study the diagnostic outcome of ultrasound screening related to the educational level and skills of the user

  3. Time to definitive treatment [ Time Frame: 3 months ]
    Time from admittance to definitive treatment

  4. Time to discharge [ Time Frame: 3 months ]
    Time from patients admittance to discharge from hospital

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01331187

Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust
Levanger, Norway, 7600
Sponsors and Collaborators
Levanger Hospital
Norwegian University of Science and Technology
Study Chair: Havard Dalen, MD, PhD Levanger Hospital/Norwegian University of Science an Technology

Additional Information:

Responsible Party: Håvard Dalen, MD, PhD; Consultant, Levanger Hospital and Norwegian University of Science and Technology Identifier: NCT01331187     History of Changes
Other Study ID Numbers: LH-2011-1
First Posted: April 7, 2011    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: April 2011

Keywords provided by Levanger Hospital:
Heart failure
pocket-size device

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