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Ultrasound Guided Vascular Access in Pediatric Intensive Care Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jana Stockwell, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00207883
First received: September 13, 2005
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to see how fast and accurate two different techniques used by physicians to insert catheters in children are. Catheters are tiny tubes which carry fluids, blood and sometimes liquid food into a person's vein. The technique currently used relies on the physical landmarks and using fingers to feel the anatomy in which to place the catheter in the vein or artery. The investigators are changing to a technique where they will use ultrasound at the patient's bedside to help physicians with placing the catheter into the blood vessel. They are comparing the use of these two methods to determine which is faster and requires fewer needle sticks.

Condition
Critical Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound Guided Vascular Access: A Prospective Comparison Study

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Primary Outcome Measures:
  • Central Line Placement Success [ Time Frame: immediate ]
    Success was defined as central venous catheter being able to thread into the vessel over the guide wire.


Secondary Outcome Measures:
  • Time to Successful Central Line Placement [ Time Frame: immediate ]
    Time, in seconds, till successful guide wire placement was achieved.


Enrollment: 212
Study Start Date: January 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Landmark
Procedure/Surgery: Use of landmarks for central line placement
Ultrasound guided
Procedure/Surgery: Use of ultrasound for central line placement

Detailed Description:

In critically ill patients, central venous access is essential for volume resuscitation, administration of medicines (such as vasoactive drugs, antibiotics or chemotherapy), administration of blood products, and hemodynamic monitoring. Placement of central venous catheters (CVC) occurs commonly with over 200,000 CVCs placed in adults and children yearly. At Egleston 222 central venous lines were placed last year and 178 CVCs YTD through October. Obtaining central venous access in critically ill children can be a difficult procedure with many potential complications. These complications can include, but are not limited to, hematoma at the site, hemothorax, pneumothorax, need to change sites, and injury to surrounding structures. The complication rates for CVCs in children is reported anywhere from 2.5% to 22%. All too frequently CVC placement in children is unsuccessful anywhere from 5% of the time to greater than 19%.

Studies in adults have shown ultrasound guided central venous access to decrease the number of attempts required to cannulate the vein. Ultrasound (US) guidance is also able to decrease the time required to cannulate the vessel. A meta analysis of ultrasound guided central venous access in adults concluded that for internal jugular procedures ultrasound guidance was significantly more successful than the landmark technique alone. With the recent focus on patient safety and clinical outcomes the American College of Emergency Physicians published a policy statement included in the guidelines use of US guidance for central venous access in a list of primary applications for ultrasound in the emergency department.

Evidence for US guidance in children is currently found mainly in the anesthesia literature. The 2003 NICE sponsored meta-analysis showed an overall relative risk reduction of 85% for failed placement and 73% for complications of internal jugular placement in pediatric patients in an operating room. Because of small sample sizes (each < 100 patients) and only the internal jugular approach being studied, definitive conclusions regarding other sites are ongoing. Currently there are no prospective studies evaluating the use of ultrasound guided central venous access in children in a pediatric intensive care unit. Also, studies addressing the use of US guided CVC placement in femoral access, the major site used in children, is also lacking.

Our proposal is to prove that US guided CVC will decrease the overall time required to cannulate the vessel by increasing the probability of successful cannulation by the first operator, decreasing the number of skin punctures to obtain access, eliminating the need to change sites for access, and improving the probability of access. Additionally we believe that US guided CVC placement would decrease the likelihood of untoward effects including but not limited to severe hematoma requiring attempts at additional sites, inadvertent puncture of the wrong vessel, or hemothorax/pneumothorax.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted to the Pediatric Intensive care Unit (PICU) at Children's Healthcare of Atlanta at Egleston
Criteria

Inclusion Criteria:

  • All patients admitted to the pediatric intensive care unit (PICU) who require vascular access.

Exclusion Criteria:

  • Age greater than 18 years.
  • Any vascular catheter placed outside of the pediatric intensive care unit at Egleston.
  • Any vascular catheter placed by a physician other than a member of the pediatric critical care team.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00207883

Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Jana A Stockwell, MD Children's Healthcare of Atlanta
Principal Investigator: Curt Froehlich, MD Children's Healthcare of Atlanta
  More Information

Publications:
Diggle PJ, Liang KY, Zeger S: Analysis of Longitudinal Data. New York, NY, Oxford University Press, 1995, pp 162-168, 185- 189

Responsible Party: Jana Stockwell, MD, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00207883     History of Changes
Other Study ID Numbers: 04-130
Study First Received: September 13, 2005
Results First Received: June 1, 2009
Last Updated: March 22, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Children's Healthcare of Atlanta:
Vascular Access
Ultrasound
Pediatric
Pediatric intensive care patient

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 24, 2017