Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis
Primary Purpose
DVT
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound assessment of DVT
Sponsored by
About this trial
This is an interventional prevention trial for DVT focused on measuring DVT, TKA, THA, Hip Fracture, High risk, Ultrasound, U/S
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
Sites / Locations
- Toronto Western Hopspital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ultrasound assessment of DVT
Arm Description
DVT ultrasound vs Clinical assessment in high-risk patients following hip fracture and major arthroplasty before the patients become symptomatic.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03443310
First Posted
February 11, 2013
Last Updated
February 16, 2018
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03443310
Brief Title
Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DVT
Keywords
DVT, TKA, THA, Hip Fracture, High risk, Ultrasound, U/S
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients who have symptomatic DVT undergo diagnostic venous duplex examination.
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound assessment of DVT
Arm Type
Other
Arm Description
DVT ultrasound vs Clinical assessment in high-risk patients following hip fracture and major arthroplasty before the patients become symptomatic.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound assessment of DVT
Intervention Description
Using Ultrasound in assessing DVT in high-risk patients following hip fracture and major arthroplasty before the patients become symptomatic.
Primary Outcome Measure Information:
Title
The accuracy of a positive bedside ultrasound scan
Description
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 Outcome Measure Information:
Title
The degree of technical difficulty
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Toronto Western Hopspital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis
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