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Ultrasound Guided Vascular Access in Pediatric Intensive Care Patients

Ultrasound Guided Vascular Access: A Prospective Comparison Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00207883
Enrollment
212
Registered
2005-09-21
Start date
2005-01-31
Completion date
2007-12-31
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

Vascular Access, Ultrasound, Pediatric, Pediatric intensive care patient

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 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.

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.

Interventions

None listed

Sponsors

Children's Healthcare of Atlanta
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Central Line Placement SuccessimmediateSuccess was defined as central venous catheter being able to thread into the vessel over the guide wire.

Secondary

MeasureTime frameDescription
Time to Successful Central Line PlacementimmediateTime, in seconds, till successful guide wire placement was achieved.

Countries

United States

Participant flow

Participants by arm

ArmCount
Group 1 - LM
traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
93
Group 2 - US
ultra sound assisted CVC placement
119
Total212

Baseline characteristics

CharacteristicGroup 1 - LMGroup 2 - USTotal
Age, Categorical
<=18 years
93 Participants119 Participants212 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Sex/Gender, Customized
Patients for whom gender was recorded
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
18 / 9310 / 119
serious
Total, serious adverse events
0 / 930 / 119

Outcome results

Primary

Central Line Placement Success

Success was defined as central venous catheter being able to thread into the vessel over the guide wire.

Time frame: immediate

Population: Population consisted of critically ill children requiring placement of a central venous catheter.

ArmMeasureValue (NUMBER)
Group 1 - LMCentral Line Placement Success82 participants
Group 2 - USCentral Line Placement Success108 participants
p-value: <0.001Fisher Exact
Secondary

Time to Successful Central Line Placement

Time, in seconds, till successful guide wire placement was achieved.

Time frame: immediate

Population: Critically ill children requiring central venous access.

ArmMeasureValue (MEDIAN)
Group 1 - LMTime to Successful Central Line Placement269 seconds
Group 2 - USTime to Successful Central Line Placement150 seconds

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026