Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis

NCT03443310 | Completed

• 1 other identifier: 11-0384-A
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as a prospective comparative study. All patients will receive prophylactic anticoagulation according to routine hospital protocol after surgery. A bedside ultrasound examination will be performed by a trained anesthesiologist prior to the surgery and then daily beginning on postoperative day 2 until patient discharge.

Conditions

DVT

Keywords

DVT; TKA; THA; Hip Fracture; High risk; Ultrasound; U/S

Outcome Measures

Primary Outcomes (1)

• The accuracy of a positive bedside ultrasound scan

  To evaluate the accuracy of a positive bedside ultrasound scan as compared to clinical assessment for the detection of an occluding DVT.

  post operative day 2

Secondary Outcomes (1)

• The degree of technical difficulty

  from start to of bedside compression test up to 1 hour

Study Arms (1)

Ultrasound assessment of DVT

OTHER

DVT ultrasound vs Clinical assessment in high-risk patients following hip fracture and major arthroplasty before the patients become symptomatic.

Procedure: Ultrasound assessment of DVT

Interventions

Ultrasound assessment of DVT PROCEDURE

Using Ultrasound in assessing DVT in high-risk patients following hip fracture and major arthroplasty before the patients become symptomatic.

Ultrasound assessment of DVT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-III
• years of age, inclusive
• kg, inclusive
• cm of height or greater
• Patients who are scheduled to have surgical repair of the fractured hip and those who will have unilateral or bilateral, primary or revision, hip or knee arthroplasty.

You may not qualify if:

• The presence of indwelling femoral vascular catheter or dialysis vascular shunts in the operative leg
• An above-knee amputation
• The inability to access all two landmarks (femoral and popliteal veins) for two-point ultrasonography because of the presence of a cast, external fixation apparatus, or other obstacles

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hopspital

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who have symptomatic DVT undergo diagnostic venous duplex examination.

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 23, 2018
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

CA (1)