Influence of Routinely Adding Ultrasound Screening in Medical Department
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|ClinicalTrials.gov Identifier: NCT01331187|
Recruitment Status : Completed
First Posted : April 7, 2011
Last Update Posted : June 1, 2012
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Time to definitive diagnosis [ Time Frame: 3 months ]Time from admittance to definitive diagnosis
- 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.
- 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
- Time to definitive treatment [ Time Frame: 3 months ]Time from admittance to definitive treatment
- Time to discharge [ Time Frame: 3 months ]Time from patients admittance to discharge from hospital
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 ClinicalTrials.gov identifier (NCT number): NCT01331187
|Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust|
|Levanger, Norway, 7600|
|Study Chair:||Havard Dalen, MD, PhD||Levanger Hospital/Norwegian University of Science an Technology|