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

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.
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):

Study Description
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.

Condition or disease Intervention/treatment
Need for Central Venous Access Procedure: central line placement Device: Ultrasound

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
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
Study Start Date : May 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Patients With Arterial Punctures [ Time Frame: Up to 410 seconds ]
    The count (%) of patients with arterial punctures is presented.

  3. Patients With Complications [ Time Frame: Up to 410 seconds ]
    The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented.

  4. Time to Successful Cannulation [ Time Frame: Up to 410 seconds ]

Eligibility Criteria

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

Publications:
Responsible Party: Matias Bruzoni, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01680666     History of Changes
Other Study ID Numbers: IRB-8943
First Posted: September 7, 2012    Key Record Dates
Results First Posted: February 11, 2015
Last Update Posted: November 9, 2017
Last Verified: October 2017