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Pediatric Radial Arterial Cannulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenichi Ueda, University of Iowa
ClinicalTrials.gov Identifier:
NCT01276158
First received: January 11, 2011
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
This prospective randomized study was designed to compare ultrasound guided technique with Doppler assisted technique for radial arterial cannulation in infant and small children.

Condition Intervention
Anesthesia Procedure: Ultrasound Procedure: Doppler

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-image Versus Doppler-guided Radial Artery Cannulation in Infants and Small Children

Resource links provided by NLM:


Further study details as provided by Kenichi Ueda, University of Iowa:

Primary Outcome Measures:
  • The primary object is to compare the first attempt success rate between each group. [ Time Frame: 10 minutes ]

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 ]

Enrollment: 104
Actual Study Start Date: May 2011
Study Completion Date: December 2011
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

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.
  Eligibility

Ages Eligible for Study:   up to 48 Months   (Child)
Sexes Eligible for Study:   All
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
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: 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

Responsible Party: Kenichi Ueda, Clinical Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01276158     History of Changes
Other Study ID Numbers: 200905711
Study First Received: January 11, 2011
Last Updated: March 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

ClinicalTrials.gov processed this record on August 18, 2017