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

Terminated

• Conditions: DEEP VEIN THROMBOSIS

• Registration Number: NCT01045759
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-11
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Subgroup analysis: difficulty of exam	48 hours window from detailed US
Subgroup analysis: specific examiner	48 hours window from detailed US
Subgroup analysis: DVT location	at study conclusion
Subgroup analysis: calf vein thrombosis	at study conclusion
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: training level of examiner	48 hours window from detailed US
Subgroup analysis: presence or absence of pulmonary embolism	at study conclusion
Subgroup analysis: location of thrombus (proximal or distal)	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: presence or absence of calf vein thrombosis	at study conclusion

Trial Locations

Locations (1)

University of missouri healthcare; 🇺🇸 Columbia, Missouri, United States