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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:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01680666
First received: August 28, 2012
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Ultrasound Versus Landmark Guided Central Venous Access in Children

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Success of central venous cannulation at first attempt. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total number of venous cannulation attempts [ Designated as safety issue: Yes ]
  • Access time in seconds [ Designated as safety issue: Yes ]
  • Number of arterial punctures [ Designated as safety issue: Yes ]
  • Number of complications [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01680666     History of Changes
Other Study ID Numbers: IRB-8943
Study First Received: August 28, 2012
Last Updated: September 4, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013