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):
Matias Bruzoni, Stanford University
ClinicalTrials.gov Identifier:
NCT01680666
First received: August 28, 2012
Last updated: January 26, 2015
Last verified: January 2015
Results First Received: January 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Need for Central Venous Access
Interventions: Procedure: central line placement
Device: Ultrasound

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Landmark Guided In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon’s preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
Ultrasound Guided In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon’s preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.

Participant Flow:   Overall Study
    Landmark Guided     Ultrasound Guided  
STARTED     84     66  
COMPLETED     84     66  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Landmark Guided All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia were approached for inclusion in the study. Children known preoperatively to have non-patency of central veins or coagulopathy were excluded from the study. Patients with previous multiple line placements were screened for deep venous thrombosis using Doppler ultrasound. Patients were enrolled by a member of the study team, and informed consent for the study was obtained from the patient’s legal guardian.
Ultrasound Guided All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia were approached for inclusion in the study. Children known preoperatively to have non-patency of central veins or coagulopathy were excluded from the study. Patients with previous multiple line placements were screened for deep venous thrombosis using Doppler ultrasound. Patients were enrolled by a member of the study team, and informed consent for the study was obtained from the patient’s legal guardian.
Total Total of all reporting groups

Baseline Measures
    Landmark Guided     Ultrasound Guided     Total  
Number of Participants  
[units: participants]
  84     66     150  
Age  
[units: participants]
     
<=18 years     84     66     150  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ( Full Range )
  8  
  ( 0 to 18 )  
  5  
  ( 0 to 18 )  
  7  
  ( 0 to 18 )  
Gender  
[units: participants]
     
Female     31     23     54  
Male     53     43     96  
Region of Enrollment  
[units: participants]
     
United States     84     66     150  



  Outcome Measures

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

2.  Secondary:   Total Number of Venous Cannulation Attempts   [ Time Frame: April 2008-September 2011 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Number of Arterial Punctures   [ Time Frame: April 2008-September 2011 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Number of Complications   [ Time Frame: April 2008-September 2011 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Matias Bruzoni, MD
Organization: Stanford University
phone: 650-723-6439
e-mail: mbruzoni@stanford.edu


No publications provided


Responsible Party: Matias Bruzoni, Stanford University
ClinicalTrials.gov Identifier: NCT01680666     History of Changes
Other Study ID Numbers: IRB-8943
Study First Received: August 28, 2012
Results First Received: January 26, 2015
Last Updated: January 26, 2015
Health Authority: United States: Institutional Review Board