Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns
Primary Purpose
Vascular Access Complication
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arterial Line Placement
Sponsored by

About this trial
This is an interventional diagnostic trial for Vascular Access Complication
Eligibility Criteria
Inclusion Criteria:
- Patients requiring arterial line placement.
Exclusion Criteria:
- Adults Unable to Consent
- Members of Vulnerable Populations
Sites / Locations
- Lewis Katz School of Medicine at Temple University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ultrasound Guided A-Line Placement
Landmark Guided A-line Placement
Arm Description
Patients in this group will have ultrasound guided arterial line placement.
Patients in this group will have landmark guided arterial line placement.
Outcomes
Primary Outcome Measures
Superiority of Method of arterial line placement
Number of attempts until successful cannulation.
Secondary Outcome Measures
Success of method
Completion of arterial line placement after three attempts
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03326739
Brief Title
Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns
Official Title
Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Critically ill patients in the emergency department commonly require arterial line placement for continuous direct blood pressure monitoring, frequent arterial blood gas sampling, and frequent blood sampling. Trans-radial catheterization has been shown to reduce access site complications and increase patient comfort compared to trans-femoral access. Radial artery access on the first attempt is optimal; attempts at reentry delay care and increase the risk of vascular spasm, hematoma, infection, neurovascular injury, and pain. The traditional pulse palpation method of radial artery cannulation can be challenging, especially in patients with weak pulses (i.e. morbidly obese or hypotensive individuals).
A review of literature suggests that ultrasound guided trans-radial catheterization compared to standard pulse palpation reduces access time and increases rate of first-entry success when performed by physicians trained in ultrasound. Thus, complications ascribed to reentry are prevented and timely care is provided.
To the investigator's knowledge, only one other prospective study has been conducted to assess the utility of ultrasound guided radial artery cannulation in the emergency department. Due to the paucity of literature to support the use of ultrasound guided trans-radial catheterization in critically ill patients, the study will aim to provide further data on the topic. Both techniques are considered standard of care.
Detailed Description
Patients presenting to the Emergency Department 18 years old or greater, who do not belong to a vulnerable group, requiring arterial line placement will be included in this trial. The investigators will randomize each patient into LM vs US. Data collected will include number of attempts, success rate, and time for procedure to be completed. PGY-1 residents will perform the arterial line placement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Access Complication
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound Guided A-Line Placement
Arm Type
Active Comparator
Arm Description
Patients in this group will have ultrasound guided arterial line placement.
Arm Title
Landmark Guided A-line Placement
Arm Type
Active Comparator
Arm Description
Patients in this group will have landmark guided arterial line placement.
Intervention Type
Procedure
Intervention Name(s)
Arterial Line Placement
Intervention Description
arterial line placement
Primary Outcome Measure Information:
Title
Superiority of Method of arterial line placement
Description
Number of attempts until successful cannulation.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Success of method
Description
Completion of arterial line placement after three attempts
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients requiring arterial line placement.
Exclusion Criteria:
Adults Unable to Consent
Members of Vulnerable Populations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan C Gibbons, MD
Organizational Affiliation
Lewis Katz School of Medicine at Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lewis Katz School of Medicine at Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns
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