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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Oklahoma
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Long Axis arterial line placement
Twenty four patients will undergo arterial line placements using long axis arterial line placement under ultrasound.
Procedure: Arterial line placement

The following measures will be collected and compared.

  1. Time (in seconds) required for successful placement of the arterial line. This is the time elapsed between either palpation or placement of ultrasound probe on the patient's wrist and the successful demonstration of arterial waveform on the anesthesia monitor.
  2. number of attempts, defined as forward advancements of needle, required to cannulate the artery.
  3. number of separate skin punctures.
  4. number of arteries into which entry is attempted.
Other Names:
  • Ultrasound guided (short vs Long axis)
Experimental: Short Axis arterial line placement
Twenty four patients will undergo arterial line placements using short axis arterial line placement under ultrasound.
Procedure: Arterial line placement

The following measures will be collected and compared.

  1. Time (in seconds) required for successful placement of the arterial line. This is the time elapsed between either palpation or placement of ultrasound probe on the patient's wrist and the successful demonstration of arterial waveform on the anesthesia monitor.
  2. number of attempts, defined as forward advancements of needle, required to cannulate the artery.
  3. number of separate skin punctures.
  4. number of arteries into which entry is attempted.
Other Names:
  • Ultrasound guided (short vs Long axis)
Active Comparator: Palpation arterial line placement
Twenty four patients will undergo arterial line placements using Traditional palpation arterial line placement.
Procedure: Arterial line placement

The following measures will be collected and compared.

  1. Time (in seconds) required for successful placement of the arterial line. This is the time elapsed between either palpation or placement of ultrasound probe on the patient's wrist and the successful demonstration of arterial waveform on the anesthesia monitor.
  2. number of attempts, defined as forward advancements of needle, required to cannulate the artery.
  3. number of separate skin punctures.
  4. number of arteries into which entry is attempted.
Other Names:
  • Ultrasound guided (short vs Long axis)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oklahoma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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