Point of Care Ultrasound For The Diagnosis Of Deep Venous Thrombosis And Its Effect On Length Of Hospital Stay
Primary Purpose
Deep Venous Thromboses, Deep Venous Thrombosis of Left Leg, Deep Venous Thrombosis of Right Leg
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Point Of Care Ultrasound (PODUS)
Echo Doppler Ultrasound (EDUS)
Sponsored by
About this trial
This is an interventional diagnostic trial for Deep Venous Thromboses focused on measuring Ultrasonography, Point-of-care systems, Deep venous thrombosis, Hospitalization
Eligibility Criteria
Inclusion Criteria:
- Low, moderate or high suspicion of DVT by Wells Criteria.
- Patients with Echo-Doppler Ultrasonography already requested in the hospital system.
Exclusion Criteria:
- Myocardial Infarction, Stroke or Cardiac Surgery within 3 months prior to hospital admission;
- Renal Chronic Disease (Clinical Stages IV and V);
- Congestive Heart Failure (NYHA IV);
- Pregnancy;
- Previous episode of DVT in the same leg that of the current DVT suspicion;
- Patients already in treatment for DVT or taking anticoagulants for any other reason.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
POCUS + EDUS
Echo Doppler Ultrasound (EDUS)
Arm Description
Patients were first submitted to Point Of Care Ultrasound (POCUS) and then to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
Outcomes
Primary Outcome Measures
Length of hospital stay
Length of hospital stay
Secondary Outcome Measures
Time to first diagnostic information
Time to first diagnostic information
Time to therapeutic decision making / prescription
Time to therapeutic decision making / prescription
Full Information
NCT ID
NCT03038893
First Posted
January 31, 2017
Last Updated
January 31, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03038893
Brief Title
Point of Care Ultrasound For The Diagnosis Of Deep Venous Thrombosis And Its Effect On Length Of Hospital Stay
Official Title
Point of Care Ultrasound For The Diagnosis Of Deep Venous Thrombosis And Its Effect On Length Of Hospital Stay
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
January 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Clinical Trial on the use of Point Of Care Ultrasound for the diagnosis of deep venous thrombosis (DVT) and its effect on length of hospital stay. 25 participants with suspicion of DVT according to Wells Criteria were randomized to one of two groups: Point of Care Ultrasound and Echo Doppler Ultrasound (POCUS + EDUS), and the control group was submitted only to the Echo Doppler Ultrasound (EDUS). The primary outcome was hospital stay.
Detailed Description
Because of high mortality associated with venous thrombosis (pulmonary embolism and deep venous thrombosis - DVT) the early recognition and therapeutics of its condition are crucial. Point of Care Ultrasound (POCUS) is a method with high sensibility to diagnose DVT and it is as accurate as Echo Doppler Ultrasound (EDUS), however the use of POCUS for diagnosis of DVT in the emergency care still presents resistance. This is a Clinical Trial on the use of POCUS for the diagnosis of DVT and its effect on length of hospital stay. 25 participants were randomized into two groups. The randomization was done through the random.org site in blocks of 4, a randomization list was with one researcher (blind) of the study. The experimental group was first submitted to POCUS in the Emergency Room, performed by a resident physician of Internal Medicine with training in POCUS, then after submitted to EDUS in the Radiology Service by a Radiologist. The control group was submitted only to EDUS in the Radiology Service. The 2-point compression technique was used, as described in previous studies, using the portable ultrasound device (M-turbo Sonosite) with a high frequency linear transducer (5-10 MHZ). The sites used in the evaluation were the popliteal site comprising the popliteal vein and trifurcation of the popliteal vein and the femoral point in which comprises the sapheno-femoral junction, the common femoral vein and the superficial femoral vein, all evaluated in the transverse plane. The result was considered positive for DVT when the vessel evaluated showed no compressibility and / or presented echogenic material in the lumen of the vein. After the randomization, the patients were followed for a period of 30 days, being evaluated in three moments: initial evaluation, at 7 and 30 days of the initial evaluation. Whenever possible, each evaluation was in person. In the initial evaluation, the participant's demographics, date and time of arrival at the Emergency Service, previous illnesses, Wells criteria score and reason for the initial care were collected. Participants randomized to the POCUS + EDUS group had recorded date and time of ultrasound at the bedside and, if there was confirmation of DVT, these data were collected by the resident physician, blinded for the Echo Doppler Ultrasound results. EDUS data, such as date and time of the examination request, date and time of the release of the exam report, confirmation of DVT, date and time of discharge were collected by another researcher, blinded to the participant's group and to the POCUS's results. After 7 and 30 days the outcomes were recorded: time for a first diagnostic information, time to therapeutic decision making / prescription, length of hospital stay, death, pulmonary thromboembolism, bleeding or other complication, re-hospitalization, evolution to DVT in cases that were initially negative.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Venous Thromboses, Deep Venous Thrombosis of Left Leg, Deep Venous Thrombosis of Right Leg, Deep Venous Thrombosis Proximal
Keywords
Ultrasonography, Point-of-care systems, Deep venous thrombosis, Hospitalization
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Single Blind Masking
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
POCUS + EDUS
Arm Type
Experimental
Arm Description
Patients were first submitted to Point Of Care Ultrasound (POCUS) and then to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
Arm Title
Echo Doppler Ultrasound (EDUS)
Arm Type
Active Comparator
Arm Description
Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
Intervention Type
Diagnostic Test
Intervention Name(s)
Point Of Care Ultrasound (PODUS)
Intervention Description
Patients were first submitted to Point Of Care Ultrasound (POCUS) and then to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
Intervention Type
Diagnostic Test
Intervention Name(s)
Echo Doppler Ultrasound (EDUS)
Intervention Description
Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Time to first diagnostic information
Description
Time to first diagnostic information
Time Frame
Up to 30 days
Title
Time to therapeutic decision making / prescription
Description
Time to therapeutic decision making / prescription
Time Frame
Up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Low, moderate or high suspicion of DVT by Wells Criteria.
Patients with Echo-Doppler Ultrasonography already requested in the hospital system.
Exclusion Criteria:
Myocardial Infarction, Stroke or Cardiac Surgery within 3 months prior to hospital admission;
Renal Chronic Disease (Clinical Stages IV and V);
Congestive Heart Failure (NYHA IV);
Pregnancy;
Previous episode of DVT in the same leg that of the current DVT suspicion;
Patients already in treatment for DVT or taking anticoagulants for any other reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Claudia Tonelli
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Point of Care Ultrasound For The Diagnosis Of Deep Venous Thrombosis And Its Effect On Length Of Hospital Stay
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