Point of Care Ultrasound (US) Versus Detailed Radiology US for Deep Vein Thrombosis (DVT)

Brief Summary

Official Title: “Intensivist Performed Limited B Mode Compression Ultrasound for Diagnosis of Deep Vein Thrombosis in the Intensive Care Unit”

Deep vein thrombosis is a common problem in the intensive care unit and diagnosis is often delayed due to limited availability of a formal duplex ultrasound. Physician performed 2 point compression ultrasonography has been shown to have reasonable accuracy when performed in the emergency department and outpatient setting, but has not been studied on patients in the intensive care unit. We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography.

  • Study Type: Observational
  • Study Design: Time Perspective: Prospective
  • Study Primary Completion Date: November 2010

Outcome Measures for this Clinical Trial

Primary Measures

  • The agreement between physician performed ultrasound and formal duplex ultrasonography for detection of proximal deep vein thrombosis.
    • Time Frame: 48 hours window from detailed US
      Safety Issue?: No

Secondary Measures

  • Subgroup analysis: location of thrombus (proximal or distal)
    • Time Frame: 48 hours window from detailed US
      Safety Issue?: No
  • Subgroup analysis: number of days in the hospital prior to exam
    • Time Frame: 48 hours window from detailed US
      Safety Issue?: No
  • Subgroup analysis: body mass index (BMI)
    • Time Frame: 48 hours window from detailed US
      Safety Issue?: No
  • Subgroup analysis: weight gain from admission to the time of the exam
    • Time Frame: 48 hours window from detailed US
      Safety Issue?: No
  • Subgroup analysis: training level of examiner
    • Time Frame: 48 hours window from detailed US
      Safety Issue?: No
  • Subgroup analysis: difficulty of exam
    • Time Frame: 48 hours window from detailed US
      Safety Issue?: No
  • Subgroup analysis: specific examiner
    • Time Frame: 48 hours window from detailed US
      Safety Issue?: No
  • Subgroup analysis: presence or absence of calf vein thrombosis
    • Time Frame: at study conclusion
      Safety Issue?: No
  • Subgroup analysis: presence or absence of pulmonary embolism
    • Time Frame: at study conclusion
      Safety Issue?: No
  • Subgroup analysis: DVT location
    • Time Frame: at study conclusion
      Safety Issue?: No
  • Subgroup analysis: calf vein thrombosis
    • Time Frame: at study conclusion
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Male and female adults at least 18 years of age
  • Duplex ultrasonography ordered by treating team
  • Admission to the Medical, Cardiac, Burn, or Surgical intensive care units

Exclusion Criteria

  • Patients less than 18 years of age
  • Patients with a known current DVT
  • patients on whom the exam cannot be performed (above the knee amputation, severe cellulitis of groin or popliteal fossa, hip or knee fracture)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • University of Missouri-Columbia
  • Provider of Information About this Clinical Study
    • Casey Stahlheber MD and Ousama Dabbagh MD, University of Missouri-Columbia
  • Overall Contact(s)
    • OUSAMA DABBAGH, MD FCCP, 573 882 0808, dabbagho@health.missouri.edu

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01045759