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Clinical Trials/NCT03443310
NCT03443310
Completed
Not Applicable

A Pilot Study of Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis in High Risk Patients Following Hip Fracture and Major Joint Arthroplasty

University Health Network, Toronto1 site in 1 country800 target enrollmentJuly 2013
ConditionsDVT

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
DVT
Sponsor
University Health Network, Toronto
Enrollment
800
Locations
1
Primary Endpoint
The accuracy of a positive bedside ultrasound scan
Status
Completed
Last Updated
8 years ago

Overview

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.

Detailed Description

Recent studies conducted at the emergency department evaluated the usefulness of an abbreviated bedside compression ultrasound test for diagnosis of Deep Venous Thrombosis (DVT) in the proximal region. This abbreviated ultrasound test conducted in the groin and popliteal regions to assess the compressibility of the femoral and popliteal veins required as little as 3.5 min to complete 15 and can be easily mastered by residents with minimum training. These studies showed a promising sensitivity ranging from 70% to 100% and a specificity ranging from 75.9% to 99.6%. Anesthesiologists are now well-trained in performing ultrasound scans as they perform ultrasound-guided peripheral nerve blocks routinely. Scanning for significant proximal DVT could potentially be anesthesiologists' extended role as they follow up patients who underwent orthopedic surgeries for postoperative pain control as part of the acute pain service.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
December 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ASA physical status I-III
  • 18-85 years of age, inclusive
  • 50-110 kg, inclusive
  • 150 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

The accuracy of a positive bedside ultrasound scan

Time Frame: post operative day 2

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

Secondary Outcomes

  • The degree of technical difficulty(from start to of bedside compression test up to 1 hour)

Study Sites (1)

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