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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: November 9, 2017
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
August 28, 2012
September 7, 2012
January 26, 2015
February 11, 2015
November 9, 2017
May 2009
December 2011   (Final data collection date for primary outcome measure)
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.
Success of Central Venous Cannulation at First Attempt.
Complete list of historical versions of study NCT01680666 on ClinicalTrials.gov Archive Site
  • 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.
  • Patients With Arterial Punctures [ Time Frame: Up to 410 seconds ]
    The count (%) of patients with arterial punctures is presented.
  • Patients With Complications [ Time Frame: Up to 410 seconds ]
    The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented.
  • Time to Successful Cannulation [ Time Frame: Up to 410 seconds ]
  • Total Number of Venous Cannulation Attempts
  • Access time in seconds
  • Number of Arterial Punctures
  • Number of Complications
Not Provided
Not Provided
 
A Prospective Trial of Ultrasound Versus Landmark Guided Central Venous Access in the Pediatric Population
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Need for Central Venous Access
  • Procedure: central line placement
    central line placement
  • Device: Ultrasound
    Ultrasound guided central venous access
    Other Names:
    • Sonosite, Bothel, WA
    • Aloka, Wallingford, CT
  • Active Comparator: landmark guided
    central line placement
    Intervention: Procedure: central line placement
  • Active Comparator: ultrasound guided
    central line placement
    Interventions:
    • Procedure: central line placement
    • Device: Ultrasound
Bruzoni M, Slater BJ, Wall J, St Peter SD, Dutta S. A prospective randomized trial of ultrasound- vs landmark-guided central venous access in the pediatric population. J Am Coll Surg. 2013 May;216(5):939-43. doi: 10.1016/j.jamcollsurg.2013.01.054. Epub 2013 Mar 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01680666
IRB-8943
No
Not Provided
Not Provided
Matias Bruzoni, Stanford University
Stanford University
Not Provided
Not Provided
Stanford University
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP