Pediatric Radial Arterial Cannulation

Ultrasound-image Versus Doppler-guided Radial Artery Cannulation in Infants and Small Children

This prospective randomized study was designed to compare ultrasound guided technique with Doppler assisted technique for radial arterial cannulation in infant and small children.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Ultrasound; Procedure: Doppler

Detailed Description

In infants, percutaneous cannulation of radial artery requires considerable expertise. People have been using Doppler guided radial artery cannulation technique to improve success rate for more than 20 years. Recently, Ultrasound sonography has been utilized for central line placement in pediatrics. The purpose of this study is whether ultrasound guided radial artery cannulation technique improves the success rate compared to traditional doppler guided technique.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria

  1. Pediatric patient undergoing scheduled major surgery which require continuous arterial pressure monitoring
  2. Term neonates and children < 4 years old weighing >/= 3 kg and < 12 kg

Exclusion Criteria:

• Exclusion criteria

  1. Patients with a skin wound or infection around puncture site
  2. Abnormal circulation in the hand (known vascular compromise, mottling, cool skin temp relative to other hand, poor capillary refill)
  3. Recent radial arterial puncture (less than 1 month)
  4. Any emergency surgery or profound hemodynamic instability requiring urgent arterial cannulation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound; Arterial line placed with Ultrasound guidance.	Procedure: Ultrasound; Ultrasound used to place arterial line
Active Comparator: Doppler; Arterial line placed with doppler guidance	Procedure: Doppler; Doppler used to place arterial line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary object is to compare the first attempt success rate between each group.	10 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
As a secondary object, a comparison will be made between groups for overall Success rate within a 10 minute time period.	10 minutes

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Kenichi Ueda, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: January 11, 2011
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 200905711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO