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

Intensivist Performed Limited B Mode Compression Ultrasound for Diagnosis of Deep Vein Thrombosis 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 Overview

• Status: Terminated
• Conditions: DEEP VEIN THROMBOSIS

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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The agreement between physician performed ultrasound and formal duplex ultrasonography for detection of proximal deep vein thrombosis.	48 hours window from detailed US

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Casey Stahlheber, MD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: January 7, 2010
• First Submitted That Met QC Criteria: January 7, 2010
• First Posted (Estimate): January 11, 2010

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: intensive care unit; ultrasonography; VENOUS THROMBOSIS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: 1143800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO