Clinical trial NCT03443310: 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
Overall status: COMPLETED
Phase: NA
Conditions: DVT
Keywords: DVT
TKA
THA
Hip Fracture
High risk
Ultrasound
U/S
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who have symptomatic DVT undergo diagnostic venous duplex examination.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The accuracy of a positive bedside ultrasound scan
timeFrame: post operative day 2
Secondary outcomes:
measure: The degree of technical difficulty
timeFrame: from start to of bedside compression test up to 1 hour
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hopspital
state: Ontario
Study officials:
References: