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Single v Dual-Operator Ultrasound Technique for Peripheral Vascular Access in the Emergency Department

Primary Purpose

Patients With Difficult Vascular Access.

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dual Operator Ultrasound Guided IV placement
Single Operator Ultrasound Guided IV placement
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Difficult Vascular Access.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult (18 years and older) patients predicted to require intravenous cannulas and identified at triage as having moderate or difficult access based on the following criteria:

Moderate: peripheral vein is visible or palpable but difficulty is expected based on patient characteristics both clinical and historical.

Difficult: No peripheral veins visible or palpable, or two failed attempts by traditional landmarking (LM).

Exclusion Criteria:

  • Exclusion criteria will include patients who have already undergone successful pre-hospital IV placement, patients with an indwelling vascular device, patients who are critically ill (Canadian Triage Acuity Score I) or objection to study enrolment by the attending MD for any reason. If no suitable target vein can be identified with US the patient data will be collected and the patient will be excluded from the statistical analysis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Single-Operator

    Dual-Operator

    Arm Description

    For the 'Single Operator Ultrasound Guided IV placement' arm the RN operator will use the ultrasound probe to identify the target vein, and continue to hold and adjust the probe while placing the IV.

    For the 'Dual Operator Ultrasound Guided IV placement' arm the RN operator will use the US to identify the target vein, at which time the study coordinator will hold the ultrasound probe in position. The RN operator will then place the IV.

    Outcomes

    Primary Outcome Measures

    First Pass Success
    The proportion of patients in whom vascular access is obtained on the first attempt with a single skin puncture.

    Secondary Outcome Measures

    Overall Success
    The proportion of patients in whom vascular access is achieved within a maximum of three attempts at US guided placement.
    Number of Attempts
    Total number of individual skin punctures that a patient receives.
    Time to Canulation
    Measured as the time from when the Registered Nurse operator first picks up the ultrasound probe to the time when 'flashback' is seen to confirm placement.
    Patient Pain Score
    To be completed by the patient immediately after the procedure: 10cm visual analogue scale from 'painless' to 'very painful'.
    Operator Ease of Use Score
    To be completed by the Registered Nurse operator immediately after the procedure: 10cm visual analogue scale from 'very easy' to 'very difficult'.

    Full Information

    First Posted
    June 15, 2016
    Last Updated
    June 15, 2016
    Sponsor
    Sunnybrook Health Sciences Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02806180
    Brief Title
    Single v Dual-Operator Ultrasound Technique for Peripheral Vascular Access in the Emergency Department
    Official Title
    Single v Dual-Operator Ultrasound Technique for Peripheral Vascular Access in the Emergency Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sunnybrook Health Sciences Centre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a randomized controlled trial comparing the success of US guided peripheral IV placement between single vs dual-operator technique among a convenience sample of patients with moderate or difficult vascular access in a tertiary care Emergency Department.
    Detailed Description
    Gaining intravenous (IV) access is a common and important procedure in the emergency department (ED). IV access is needed to deliver drugs, enable fluid resuscitation and sample blood, and delays in gaining access can lead to patient harm. Ultrasound (US) is a commonly used tool in the ED, and the utility of ultrasound in the placement of IVs in patients with difficult access has been well described. This study aims to further guide the use of this evidence based tool by ED Registered Nurses. The focus will be comparing single-operator technique, in which the same provider manipulates the ultrasound probe while simultaneously placing the IV, to a dual-operator technique whereby a second provider manipulates the probe. Any measured advantage has implications in guiding education and practice, as well as informing future ED policy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patients With Difficult Vascular Access.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    128 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single-Operator
    Arm Type
    Experimental
    Arm Description
    For the 'Single Operator Ultrasound Guided IV placement' arm the RN operator will use the ultrasound probe to identify the target vein, and continue to hold and adjust the probe while placing the IV.
    Arm Title
    Dual-Operator
    Arm Type
    Experimental
    Arm Description
    For the 'Dual Operator Ultrasound Guided IV placement' arm the RN operator will use the US to identify the target vein, at which time the study coordinator will hold the ultrasound probe in position. The RN operator will then place the IV.
    Intervention Type
    Procedure
    Intervention Name(s)
    Dual Operator Ultrasound Guided IV placement
    Intervention Description
    Second operator holds ultrasound probe.
    Intervention Type
    Procedure
    Intervention Name(s)
    Single Operator Ultrasound Guided IV placement
    Intervention Description
    Single operator holds ultrasound probe and places IV.
    Primary Outcome Measure Information:
    Title
    First Pass Success
    Description
    The proportion of patients in whom vascular access is obtained on the first attempt with a single skin puncture.
    Time Frame
    Total procedure time (<15 minutes)
    Secondary Outcome Measure Information:
    Title
    Overall Success
    Description
    The proportion of patients in whom vascular access is achieved within a maximum of three attempts at US guided placement.
    Time Frame
    Total procedure time (<15 minutes)
    Title
    Number of Attempts
    Description
    Total number of individual skin punctures that a patient receives.
    Time Frame
    Total procedure time (<15 minutes)
    Title
    Time to Canulation
    Description
    Measured as the time from when the Registered Nurse operator first picks up the ultrasound probe to the time when 'flashback' is seen to confirm placement.
    Time Frame
    Total procedure time (<15 minutes)
    Title
    Patient Pain Score
    Description
    To be completed by the patient immediately after the procedure: 10cm visual analogue scale from 'painless' to 'very painful'.
    Time Frame
    Total procedure time (<15 minutes)
    Title
    Operator Ease of Use Score
    Description
    To be completed by the Registered Nurse operator immediately after the procedure: 10cm visual analogue scale from 'very easy' to 'very difficult'.
    Time Frame
    Total procedure time (<15 minutes)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult (18 years and older) patients predicted to require intravenous cannulas and identified at triage as having moderate or difficult access based on the following criteria: Moderate: peripheral vein is visible or palpable but difficulty is expected based on patient characteristics both clinical and historical. Difficult: No peripheral veins visible or palpable, or two failed attempts by traditional landmarking (LM). Exclusion Criteria: Exclusion criteria will include patients who have already undergone successful pre-hospital IV placement, patients with an indwelling vascular device, patients who are critically ill (Canadian Triage Acuity Score I) or objection to study enrolment by the attending MD for any reason. If no suitable target vein can be identified with US the patient data will be collected and the patient will be excluded from the statistical analysis.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Craig Brick, MD
    Phone
    6473281755
    Email
    craig.brick@mail.utoronto.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jordan Chenkin, MD, FRCPC
    Phone
    416-480-6100
    Ext
    7207
    Email
    jordan.chenkin@utoronto.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jordan Chenkin, MD, FRCPC
    Organizational Affiliation
    Sunnyrbook Health Science Centre, University of Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Single v Dual-Operator Ultrasound Technique for Peripheral Vascular Access in the Emergency Department

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