- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03326739
Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140
- Lewis Katz School of Medicine at Temple University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients requiring arterial line placement.
Exclusion Criteria:
- Adults Unable to Consent
- Members of Vulnerable Populations
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ultrasound Guided A-Line Placement
Patients in this group will have ultrasound guided arterial line placement.
|
arterial line placement
|
|
Active Comparator: Landmark Guided A-line Placement
Patients in this group will have landmark guided arterial line placement.
|
arterial line placement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Superiority of Method of arterial line placement
Time Frame: 1 day
|
Number of attempts until successful cannulation.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success of method
Time Frame: 1 day
|
Completion of arterial line placement after three attempts
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24642
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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