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Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis

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ClinicalTrials.gov Identifier: NCT03443310
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
DVT Procedure: Ultrasound assessment of DVT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients who have symptomatic DVT undergo diagnostic venous duplex examination.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study of Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis in High Risk Patients Following Hip Fracture and Major Joint Arthroplasty
Actual Study Start Date : July 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The degree of technical difficulty [ Time Frame: from start to of bedside compression test up to 1 hour ]
    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).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443310


Locations
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Canada, Ontario
Toronto Western Hopspital
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03443310     History of Changes
Other Study ID Numbers: 11-0384-A
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Keywords provided by University Health Network, Toronto:
DVT
TKA
THA
Hip Fracture
High risk
Ultrasound
U/S

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases