Ultrasound Guided Vascular Access in Pediatric Intensive Care Patients
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|ClinicalTrials.gov Identifier: NCT00207883|
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : March 23, 2017
Last Update Posted : April 18, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||212 participants|
|Official Title:||Ultrasound Guided Vascular Access: A Prospective Comparison Study|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
Procedure/Surgery: Use of landmarks for central line placement
Procedure/Surgery: Use of ultrasound for central line placement
- 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.
- Time to Successful Central Line Placement [ Time Frame: immediate ]Time, in seconds, till successful guide wire placement was achieved.
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): NCT00207883
|United States, Georgia|
|Children's Healthcare of Atlanta at Egleston|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Jana A Stockwell, MD||Children's Healthcare of Atlanta|
|Principal Investigator:||Curt Froehlich, MD||Children's Healthcare of Atlanta|