Clinical trial NCT01045759: Point of Care Ultrasound (US) Versus Detailed Radiology US for Deep Vein Thrombosis (DVT)
Official title: Intensivist Performed Limited B Mode Compression Ultrasound for Diagnosis of Deep Vein Thrombosis in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: DEEP VEIN THROMBOSIS
Keywords: VENOUS THROMBOSIS
ultrasonography
intensive care unit
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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)

Primary outcomes:
measure: The agreement between physician performed ultrasound and formal duplex ultrasonography for detection of proximal deep vein thrombosis.
timeFrame: 48 hours window from detailed US
Secondary outcomes:
measure: Subgroup analysis: location of thrombus (proximal or distal)
timeFrame: 48 hours window from detailed US
measure: Subgroup analysis: number of days in the hospital prior to exam
timeFrame: 48 hours window from detailed US
measure: Subgroup analysis: body mass index (BMI)
timeFrame: 48 hours window from detailed US
measure: Subgroup analysis: weight gain from admission to the time of the exam
timeFrame: 48 hours window from detailed US
measure: Subgroup analysis: training level of examiner
timeFrame: 48 hours window from detailed US
measure: Subgroup analysis: difficulty of exam
timeFrame: 48 hours window from detailed US
measure: Subgroup analysis: specific examiner
timeFrame: 48 hours window from detailed US
measure: Subgroup analysis: presence or absence of calf vein thrombosis
timeFrame: at study conclusion
measure: Subgroup analysis: presence or absence of pulmonary embolism
timeFrame: at study conclusion
measure: Subgroup analysis: DVT location
timeFrame: at study conclusion
measure: Subgroup analysis: calf vein thrombosis
timeFrame: at study conclusion
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of missouri healthcare
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Casey Stahlheber, MD
role: PRINCIPAL_INVESTIGATOR
References: