- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00859846
Ultrasound Guided Arterial Line Placement in Long Axis Versus Short Axis in Pediatric Patients
October 11, 2018 updated by: University of Oklahoma
Comparison of Ultrasound Guided Arterial Line Placement in Long Axis Versus Short Axis in Pediatric Patients.
The use of ultrasound is becoming widespread to guide the placement of arterial lines for both vascular access and regional anesthesia in the field of anesthesia.
Arterial line placement can be challenging, especially in the pediatric population.
Frequently multiple attempts are required with relatively high failure rates.
This can result in excessive needle punctures and extended OR times.
A few studies have looked at the use of ultrasound to decrease OR time and increase success rates both in adult and pediatric populations.
These studies compared the traditional palpation method with either short axis or long axis views of the vessel using ultrasound guidance.
No study to date has compared short axis and long axis views for arterial line placement in either the pediatric or adult population.
Our study compares success rates and OR times when long and short axis methods of arterial line insertion are employed in the pediatric population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
An Arterial line is an intraoperative monitor that is frequently placed in the pediatric population.
Due to their smaller anatomy and more compliant skin, arterial lines can be more difficult to insert in the pediatric population than in adults.
Additionally, lower perfusion pressure and larger subcutaneous adipose tissue can make pulse palpation more difficult.
Ultrasound is a modality that can directly image the radial, ulnar, or brachial artery.
Along with 2D ultrasound, doppler ultrasound can be utilized to confirm that an artery is not a vein.
Once the vessel is identified, the vessel can be viewed in either the long or short access.
The ultrasound beam is only 1 millimeter thick so a practitioner must stabilize the probe to view the vessel, especially in the long axis view.
Once the artery is viewed in long axis, the needle can be directly visualized all the way into the vessel.
Visualization of a guidewire or catheter in the vessel can confirm proper arterial access.
In a short access ultrasound view, it is possible to see tissue movement and sometimes a hyperechoic (bright) dot which represents the needle.
Tissue movement can help confirm the needle is immediately above the artery at all times.
The advantage of the short axis view is that less precision is needed to hold and position the transducer than with the long axis view.
The disadvantage of the short axis view is that the operator cannot see the tip of the angiocatheter as it enters the vessel.
As a result, the proximal portion of the angiocatheter can be above the artery but the distal tip could be to the side of the artery.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- The University of Oklahoma Health Sciences Center Deparment of Anesthesiology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The investigators will identify patients 0 to 14 years of age who are classified as ASA physical status ≤4 and scheduled to have surgery under general anesthesia
Exclusion Criteria:
- History of vasculitis, autoimmune disease, Reynauds phenomenon or disease
- History of no collateral perfusion
- The absence of an upper extremity artery to cannulate such as a bilateral amputee
- A child in DHS custody
- Infection at the site of insertion
- Patient refusal.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Long Axis arterial line placement
Twenty four patients will undergo arterial line placements using long axis arterial line placement under ultrasound.
|
The following measures will be collected and compared.
Other Names:
|
|
Experimental: Short Axis arterial line placement
Twenty four patients will undergo arterial line placements using short axis arterial line placement under ultrasound.
|
The following measures will be collected and compared.
Other Names:
|
|
Active Comparator: Palpation arterial line placement
Twenty four patients will undergo arterial line placements using Traditional palpation arterial line placement.
|
The following measures will be collected and compared.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Using the long axis ultrasound view increases the success rate of arterial line insertions compared to using the short axis view.
Time Frame: 1.5 year
|
Using the long axis ultrasound view increases the success rate of arterial line
|
1.5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Using the short axis view, when successful, results in quicker insertion than when using the long axis view.
Time Frame: 1.5 year
|
Using the short axis view, when successful, results in quicker insertion than when using the long axis view.
|
1.5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alberto J de Armendi, MD, Oklahoma University Health Sciences Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Shiver S, Blaivas M, Lyon M. A prospective comparison of ultrasound-guided and blindly placed radial arterial catheters. Acad Emerg Med. 2006 Dec;13(12):1275-9. doi: 10.1197/j.aem.2006.07.015. Epub 2006 Nov 1.
- Schwemmer U, Brederlau J. [Ultrasound techniques in anesthesiology--guided vascular access using sonography]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2006 Nov;41(11):740-9. doi: 10.1055/s-2006-958847. German.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2009
Primary Completion (Actual)
September 25, 2018
Study Completion (Actual)
September 25, 2018
Study Registration Dates
First Submitted
March 9, 2009
First Submitted That Met QC Criteria
March 10, 2009
First Posted (Estimate)
March 11, 2009
Study Record Updates
Last Update Posted (Actual)
October 12, 2018
Last Update Submitted That Met QC Criteria
October 11, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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