Ultrasound Guided Arterial Line Placement in Long Axis Versus Short Axis in Pediatric Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Oklahoma.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00859846
First received: March 9, 2009
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
General Anesthesia
Procedure: Arterial line placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Ultrasound Guided Arterial Line Placement in Long Axis Versus Short Axis Versus Traditional Placement in Pediatric Patients

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Using the short axis view, when successful, results in quicker insertion than when using the long axis view. [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 74
Study Start Date: March 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arterial line placement
Patients will be randomized into one of three groups defined by the method of arterial line placement: traditional palpation or ultrasound guided in either the short axis or long axis. Twenty four patients will undergo arterial line placements for each method of insertion.
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 Name: Ultrasound guided (short vs Long axis)

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.

  Eligibility

Ages Eligible for Study:   up to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859846

Contacts
Contact: Alberto J de Armendi, MD 405/271-4351 alberto-de-armendi@ouhsc.edu
Contact: Cure A Jorge, MD 405-271-8001 ext 36017 jorge-cure@ouhsc.edu

Locations
United States, Oklahoma
The University of Oklahoma Health Sciences Center Deparment of Anesthesiology Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Jorge A Cure, MD    405-271-8001 ext 36017    jorge-cure@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Abahaya Seshachar, MD Oklahoma University Health Sciences Center
  More Information

Publications:
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00859846     History of Changes
Other Study ID Numbers: IRB 14405
Study First Received: March 9, 2009
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Arterial line
Ultrasound
Anesthesia
Pediatric

ClinicalTrials.gov processed this record on August 19, 2014