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Influence of Routinely Adding Ultrasound Screening in Medical Department

This study has been completed.
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by:
Levanger Hospital
ClinicalTrials.gov Identifier:
NCT01331187
First received: March 30, 2011
Last updated: May 31, 2012
Last verified: April 2011
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 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 Intervention
Heart Disease
Dyspnea
Aortic Disease
Kidney Disease
Liver Disease
 Procedure: Pocket-size ultrasonography
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Levanger Hospital:

Primary Outcome Measures:
  • Time to definitive diagnosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Time from admittance to definitive diagnosis


Secondary Outcome Measures:
  • Test-retest reproducibility [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.

  • Diagnostic outcome of additional ultrasound examination according to educational level of the performer [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Study the diagnostic outcome of ultrasound screening related to the educational level and skills of the user

  • Time to definitive treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Time from admittance to definitive treatment

  • Time to discharge [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Time from patients admittance to discharge from hospital


Enrollment: 600
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: NCT01331187

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

Additional Information:
Article; Point of care ultrasonography, New England Journal of Medicine 2011  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Håvard Dalen, MD, PhD; Consultant, Levanger Hospital and Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01331187     History of Changes
Other Study ID Numbers: LH-2011-1
Study First Received: March 30, 2011
Last Updated: May 31, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Levanger Hospital:
Echocardiography
Heart failure
Ultrasonography
 pocket-size device
Aorta
Education

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 May 21, 2013