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Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 11, 2013
First Posted Date  ICMJE February 23, 2018
Last Update Posted Date February 23, 2018
Actual Study Start Date  ICMJE July 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis
Official Title  ICMJE A Pilot Study of Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis in High Risk Patients Following Hip Fracture and Major Joint Arthroplasty
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE DVT
Intervention  ICMJE 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.
Study Arms  ICMJE Ultrasound assessment of DVT
DVT ultrasound vs Clinical assessment in high-risk patients following hip fracture and major arthroplasty before the patients become symptomatic.
Intervention: Procedure: Ultrasound assessment of DVT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2018)
800
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03443310
Other Study ID Numbers  ICMJE 11-0384-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Health Network, Toronto
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP