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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
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 31, 2017
    Last Updated
    January 31, 2017
    Sponsor
    Hospital de Clinicas de Porto Alegre
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    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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