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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680666
First Posted: September 7, 2012
Last Update Posted: February 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matias Bruzoni, Stanford University
  Purpose
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.

Condition Intervention
Need for Central Venous Access Procedure: central line placement Device: Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Ultrasound Versus Landmark Guided Central Venous Access in Children

Resource links provided by NLM:


Further study details as provided by Matias Bruzoni, Stanford University:

Primary Outcome Measures:
  • Success of Central Venous Cannulation at First Attempt. [ Time Frame: April 2008-September 2011 ]

Secondary Outcome Measures:
  • Total Number of Venous Cannulation Attempts [ Time Frame: April 2008-September 2011 ]
  • Number of Arterial Punctures [ Time Frame: April 2008-September 2011 ]
  • Number of Complications [ Time Frame: April 2008-September 2011 ]

Enrollment: 150
Study Start Date: May 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680666


Locations
United States, California
Stanford University
Palo Alto, California, United States, 94304
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States
Sponsors and Collaborators
Stanford University
  More Information

Responsible Party: Matias Bruzoni, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01680666     History of Changes
Other Study ID Numbers: IRB-8943
First Submitted: August 28, 2012
First Posted: September 7, 2012
Results First Submitted: January 26, 2015
Results First Posted: February 11, 2015
Last Update Posted: February 11, 2015
Last Verified: January 2015