NCT00859846

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

March 17, 2009

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

9.5 years

First QC Date

March 9, 2009

Last Update Submit

October 11, 2018

Conditions

General Anesthesia

Keywords

Arterial lineUltrasoundAnesthesiaPediatric

Outcome Measures

Primary Outcomes (1)

  • Using the long axis ultrasound view increases the success rate of arterial line insertions compared to using the short axis view.

    Using the long axis ultrasound view increases the success rate of arterial line

    1.5 year

Secondary Outcomes (1)

  • Using the short axis view, when successful, results in quicker insertion than when using the long axis view.

    1.5 year

Study Arms (3)

Long Axis arterial line placement

EXPERIMENTAL

Twenty four patients will undergo arterial line placements using long axis arterial line placement under ultrasound.

Procedure: Arterial line placement

Short Axis arterial line placement

EXPERIMENTAL

Twenty four patients will undergo arterial line placements using short axis arterial line placement under ultrasound.

Procedure: Arterial line placement

Palpation arterial line placement

ACTIVE COMPARATOR

Twenty four patients will undergo arterial line placements using Traditional palpation arterial line placement.

Procedure: Arterial line placement

Interventions

Arterial line placementPROCEDURE

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.

Also known as: Ultrasound guided (short vs Long axis)
Long Axis arterial line placementPalpation arterial line placementShort Axis arterial line placement

Eligibility Criteria

Age1 Day - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Oklahoma Health Sciences Center Deparment of Anesthesiology

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (2)

  • 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.

    PMID: 17151988BACKGROUND

  • 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.

    PMID: 17079789BACKGROUND

Study Officials

  • Alberto J de Armendi, MD

    Oklahoma University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2009

First Posted

March 11, 2009

Study Start

March 17, 2009

Primary Completion

September 25, 2018

Study Completion

September 25, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)