Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Iowa.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT01276158
First received: January 11, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Patients Requiring Radial Arterial Line Cannulation.
 Procedure: Ultrasound
Procedure: Doppler

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • The primary object is to compare the first attempt success rate between each group. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • As a secondary object, a comparison will be made between groups for overall Success rate within a 10 minute time period. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: May 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276158

Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Kenichi Ueda, MD University of Iowa
  More Information

No publications provided

Responsible Party: Kenichi Ueda, Department of Anesthesia, University of Iowa Carver College of Medicine
ClinicalTrials.gov Identifier: NCT01276158     History of Changes
Other Study ID Numbers: 200905711
Study First Received: January 11, 2011
Last Updated: January 11, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013