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

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ClinicalTrials.gov Identifier: NCT01680666
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : February 11, 2015
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Matias Bruzoni, Stanford University

Tracking Information
First Submitted Date  ICMJE August 28, 2012
First Posted Date  ICMJE September 7, 2012
Results First Submitted Date  ICMJE January 26, 2015
Results First Posted Date  ICMJE February 11, 2015
Last Update Posted Date November 9, 2017
Study Start Date  ICMJE May 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
Success of Central Venous Cannulation at First Attempt.
Change History Complete list of historical versions of study NCT01680666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
  • Total Number of Venous Cannulation Attempts
  • Access time in seconds
  • Number of Arterial Punctures
  • Number of Complications
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Trial of Ultrasound Versus Landmark Guided Central Venous Access in the Pediatric Population
Official Title  ICMJE A Prospective Randomized Trial of Ultrasound Versus Landmark Guided Central Venous Access in Children
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Need for Central Venous Access
Intervention  ICMJE
  • Procedure: central line placement
    central line placement
  • Device: Ultrasound
    Ultrasound guided central venous access
    Other Names:
    • Sonosite, Bothel, WA
    • Aloka, Wallingford, CT
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2012)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01680666
Other Study ID Numbers  ICMJE IRB-8943
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matias Bruzoni, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date October 2017

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