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

This study has been terminated.
(Investigator left the institution)
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01045759
First received: January 7, 2010
Last updated: September 29, 2016
Last verified: September 2016
  Purpose
We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography.

Condition
DEEP VEIN THROMBOSIS

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Intensivist Performed Limited B Mode Compression Ultrasound for Diagnosis of Deep Vein Thrombosis in the Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome 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 ]

Secondary Outcome Measures:
  • Subgroup analysis: location of thrombus (proximal or distal) [ Time Frame: 48 hours window from detailed US ]
  • Subgroup analysis: number of days in the hospital prior to exam [ Time Frame: 48 hours window from detailed US ]
  • Subgroup analysis: body mass index (BMI) [ Time Frame: 48 hours window from detailed US ]
  • Subgroup analysis: weight gain from admission to the time of the exam [ Time Frame: 48 hours window from detailed US ]
  • Subgroup analysis: training level of examiner [ Time Frame: 48 hours window from detailed US ]
  • Subgroup analysis: difficulty of exam [ Time Frame: 48 hours window from detailed US ]
  • Subgroup analysis: specific examiner [ Time Frame: 48 hours window from detailed US ]
  • Subgroup analysis: presence or absence of calf vein thrombosis [ Time Frame: at study conclusion ]
  • Subgroup analysis: presence or absence of pulmonary embolism [ Time Frame: at study conclusion ]
  • Subgroup analysis: DVT location [ Time Frame: at study conclusion ]
  • Subgroup analysis: calf vein thrombosis [ Time Frame: at study conclusion ]

Enrollment: 150
Study Start Date: November 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consist of adult patients admitted to the intensive care units at University hospital who have a duplex ultrasound of the lower extremities for detection of deep vein thrombosis ordered by the primary team.
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045759

Locations
United States, Missouri
University of missouri healthcare
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Casey Stahlheber, MD University of Missouri-Columbia
  More Information

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01045759     History of Changes
Other Study ID Numbers: 1143800
Study First Received: January 7, 2010
Last Updated: September 29, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Missouri-Columbia:
VENOUS THROMBOSIS
ultrasonography
intensive care unit

Additional relevant MeSH terms:
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on March 22, 2017