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CompletedNCT03443310Updated Feb 23, 2018

Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis

An interventional study of Ultrasound assessment of DVT in DVT, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-02-23.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • DVT

Keywords

  • DVT
  • TKA
  • THA
  • Hip Fracture
  • High risk
  • Ultrasound
  • U/S
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
800 participants (actual)

Study arms

  • Other
    Ultrasound assessment of DVT

    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

  • ProcedureUltrasound assessment of DVT

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

05

What researchers measure

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.

    Time frame: post operative day 2

Secondary outcomes

  1. The degree of technical difficulty

    The degree of technical difficulty in visualizing relevant veins and in determining whether a clot is present. That is, the incidence of uninterpreted test data in patients with a swollen thigh/leg after major hip or knee surgery. The degree of technical difficulty will be recorded especially in patients with a high body mass index (BMI).

    Time frame: from start to of bedside compression test up to 1 hour

06

Study locations

1 site
  • Toronto Western Hopspital
    Toronto, Ontario M5T2S8, Canada
07

Registry details

Key details

Study ID
NCT03443310
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Feb 23, 2018
Start date
Jul 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Feb 23, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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