Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207883
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2005-09-13
Brief Title:
Ultrasound Guided Vascular Access in Pediatric Intensive Care Patients
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Ultrasound Guided Vascular Access A Prospective Comparison Study
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 persons 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 patients 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
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 200000 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 25 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 hemothoraxpneumothorax
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 hemothoraxpneumothorax
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None