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

DEEP VEIN THROMBOSIS Clinical Trial

Official title:

Intensivist Performed Limited B Mode Compression Ultrasound for Diagnosis of Deep Vein Thrombosis in the Intensive Care Unit

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01045759
• Other study ID #: 1143800
• Status: Terminated
• Phase: N/A
• First received: January 7, 2010
• Last updated: September 29, 2016
• Start date: November 2009
• Est. completion date: May 2015

Study information

• Verified date: September 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• DEEP VEIN THROMBOSIS
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
United States	University of missouri healthcare	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The agreement between physician performed ultrasound and formal duplex ultrasonography for detection of proximal deep vein thrombosis.		48 hours window from detailed US	No
Secondary	Subgroup analysis: location of thrombus (proximal or distal)		48 hours window from detailed US	No
Secondary	Subgroup analysis: number of days in the hospital prior to exam		48 hours window from detailed US	No
Secondary	Subgroup analysis: body mass index (BMI)		48 hours window from detailed US	No
Secondary	Subgroup analysis: weight gain from admission to the time of the exam		48 hours window from detailed US	No
Secondary	Subgroup analysis: training level of examiner		48 hours window from detailed US	No
Secondary	Subgroup analysis: difficulty of exam		48 hours window from detailed US	No
Secondary	Subgroup analysis: specific examiner		48 hours window from detailed US	No
Secondary	Subgroup analysis: presence or absence of calf vein thrombosis		at study conclusion	No
Secondary	Subgroup analysis: presence or absence of pulmonary embolism		at study conclusion	No
Secondary	Subgroup analysis: DVT location		at study conclusion	No
Secondary	Subgroup analysis: calf vein thrombosis		at study conclusion	No