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

March 30, 2011
May 31, 2012
April 2011
June 2011   (final data collection date for primary outcome measure)
Time to definitive diagnosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Time from admittance to definitive diagnosis
Same as current
Complete list of historical versions of study NCT01331187 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Influence of Routinely Adding Ultrasound Screening in Medical Department
Influence on Diagnostics and Inpatient Workflow of Routinely Adding Ultrasound Screening by Pocket-size Ultrasound in a Medical Department

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Disease
  • Dyspnea
  • Aortic Disease
  • Kidney Disease
  • Liver Disease
  • 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
  • Other: Usual care
    No intervention, except for usual care (goal-directed diagnostics)
  • Active Comparator: Usual care
    Usual care diagnostics. No routinely ultrasound examination
    Intervention: Other: Usual care
  • Experimental: Routinely ulasonography
    Patients will routinely be examined with ultrasound at admittance in addition to usual care diagnostics
    Intervention: Procedure: Pocket-size ultrasonography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients admitted to Dep. of Medicine at Levanger Hospital

Exclusion Criteria:

  • Not able to give informed consent
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01331187
LH-2011-1
Yes
Håvard Dalen, MD, PhD; Consultant, Levanger Hospital and Norwegian University of Science and Technology
Levanger Hospital
Norwegian University of Science and Technology
Study Chair: Havard Dalen, MD, PhD Levanger Hospital/Norwegian University of Science an Technology
Levanger Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP