A Prospective Trial of Ultrasound Versus Landmark Guided Central Venous Access in the Pediatric Population

October 9, 2017 updated by: Matias Bruzoni, Stanford University

A Prospective Randomized Trial of Ultrasound Versus Landmark Guided Central Venous Access in Children

The investigators hypothesized that, in children undergoing venous cannulation for central line placement by pediatric surgeons, ultrasound-guided cannulation leads to an increase in successful venous cannulation at first attempt compared to landmark guided cannulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
    • Missouri
      • Kansas City, Missouri, United States
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia

Exclusion Criteria:

  • Preoperative proof of non-patency of central veins
  • coagulopathy
  • access site surgeon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: landmark guided
central line placement
Procedure: central line placement
central line placement
Active Comparator: ultrasound guided
central line placement
Procedure: central line placement
central line placement
Device: Ultrasound
Ultrasound guided central venous access
Other Names:
  • Sonosite, Bothel, WA
  • Aloka, Wallingford, CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of Central Venous Cannulation at First Attempt
Time Frame: Up to 410 seconds
The count (%) of patients with successful central venous cannulation at first attempt is reported.
Up to 410 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of Central Venous Cannulation Within First Three Attempts
Time Frame: Up to 410 seconds
The count (%) of patients with successful central venous cannulation within the first three attempts is reported.
Up to 410 seconds
Patients With Arterial Punctures
Time Frame: Up to 410 seconds
The count (%) of patients with arterial punctures is presented.
Up to 410 seconds
Patients With Complications
Time Frame: Up to 410 seconds
The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented.
Up to 410 seconds
Time to Successful Cannulation
Time Frame: Up to 410 seconds
Up to 410 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

September 4, 2012

First Posted (Estimate)

September 7, 2012

Study Record Updates

Last Update Posted (Actual)

November 9, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-8943

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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