Influence of Routinely Adding Ultrasound Screening in Medical Department

Sponsor
Helse Nord-Trøndelag HF (Other)
Overall Status
Completed
CT.gov ID
NCT01331187
Collaborator
Norwegian University of Science and Technology (Other)
600
1
2
2
299.4

Study Details

Study Description

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
  • Procedure: Pocket-size ultrasonography
  • Other: Usual care
N/A

Study Design

Study Type:
Interventional
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
Actual Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Time to definitive diagnosis [3 months]

    Time from admittance to definitive diagnosis

Secondary Outcome Measures

  1. Test-retest reproducibility [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 [3 months]

    Study the diagnostic outcome of ultrasound screening related to the educational level and skills of the user

  3. Time to definitive treatment [3 months]

    Time from admittance to definitive treatment

  4. Time to discharge [3 months]

    Time from patients admittance to discharge from hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust Levanger Norway 7600

Sponsors and Collaborators

  • Helse Nord-Trøndelag HF
  • Norwegian University of Science and Technology

Investigators

  • Study Chair: Havard Dalen, MD, PhD, Levanger Hospital/Norwegian University of Science an Technology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Helse Nord-Trøndelag HF
ClinicalTrials.gov Identifier:
NCT01331187
Other Study ID Numbers:
  • LH-2011-1
First Posted:
Apr 7, 2011
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021

Study Results

No Results Posted as of Nov 9, 2021