search
Back to results

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
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vascular Access Complication

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
October 17, 2017
Last Updated
January 20, 2020
Sponsor
Temple University
search

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

Learn more about this trial

Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns

We'll reach out to this number within 24 hrs