ECG-Guided Umbilical Vessel Catheterization for Acute Lymphoblastic Leukemia
Trial Summary
What is the purpose of this trial?
Umbilical venous catheters (UVC) are typically places with poor guidance and some radiological confirmation. Misplacement of the catheter could lead to its placement in other unintended anatomical areas such as the liver or the spleen, which could be detrimental in critically-ill infants. Our study aims at using a more non-invasive means of placing and continuously monitoring catheter placement using superficial electrocardiogram (ECG) tracings.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment ECG-Guided Umbilical Vessel Catheterization for Acute Lymphoblastic Leukemia?
Research shows that using an ECG (a test that records the heart's electrical activity) to guide the placement of umbilical catheters can help ensure they are positioned correctly, which is important for effective treatment. This technique has been found to be effective and safe in neonates, suggesting it could be beneficial in other settings as well.12345
Is ECG-guided umbilical vessel catheterization safe for humans?
The use of central venous catheters (CVCs) in children with acute lymphoblastic leukemia (ALL) can lead to complications like infections and blood clots, with studies showing a 17% risk of venous thromboembolism (blood clots in veins) in pediatric cancer patients with CVCs. Monitoring and careful management are important to reduce these risks.678910
How is the treatment ECG-Guided Umbilical Vessel Catheterization unique for Acute Lymphoblastic Leukemia?
ECG-Guided Umbilical Vessel Catheterization is unique because it uses an electrocardiogram (ECG) to help accurately place a catheter in the umbilical vessels, which can provide central vascular access quickly and safely. This method is typically used in newborns for other conditions, but its application in treating Acute Lymphoblastic Leukemia is novel, potentially offering a new way to deliver treatments directly into the bloodstream.12345
Eligibility Criteria
This trial is for newborn pediatric patients who weigh between 2 to 6 kilograms and either require or currently have an umbilical venous catheter (UVC). To participate, they must have consent from parents. Clinically unstable infants cannot take part in this study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
ECG readings are collected for neonatal patients with UVC to monitor catheter placement
Follow-up
Participants are monitored for safety and effectiveness after ECG monitoring
Treatment Details
Interventions
- ECG
- Umbilical Vessel Catheterization
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor