ECG-Guided Umbilical Vessel Catheterization for Acute Lymphoblastic Leukemia

Overseen By Chynna Villanueva, BS, RN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: No consent, Clinically unstable

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 15 minutes

150 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 4 5}

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

My weight is between 2 and 6 kilograms.

My child is a newborn.

Require or currently have UVC

Exclusion Criteria

Patients who are clinically unstable

Participants who do not consent or have parental consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

ECG readings are collected for neonatal patients with UVC to monitor catheter placement

15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after ECG monitoring

1-2 weeks

Treatment Details

Interventions

• ECG
• Umbilical Vessel Catheterization

Trial Overview The study is testing the use of electrocardiogram (ECG) monitoring as a non-invasive method to place and continuously monitor the position of UVCs in neonates, aiming to reduce misplacement risks associated with traditional methods.

Participant Groups

Group I: ECG Monitoring Experimental Treatment 1 Intervention

ECG readings will be collected for neonatal patients who require or currently have UVC

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Umbilical vessel catheterization. [2004]

2. Germany pubmed.ncbi.nlm.nih.gov

Umbilical catheter placement aided by coronary guidewires. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

[Positioning of umbilical vein catheter with ECG-guided technique: randomized study]. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Cardiac catheterization in the neonate. A comparison of three techniques. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

Application of a modified electrocardiogram-guided technique for umbilical venous catheterisation in neonates: A retrospective trial. [2021]

6. Poland pubmed.ncbi.nlm.nih.gov

[Evaluation of thromboembolic complications in children treated for acute lymphoblastic leukemia with Vascuport catheters]. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Infections increase the risk of central venous catheter-related thrombosis in adult acute myeloid leukemia. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Central venous catheter use and the risk of infection in children with acute lymphoblastic leukemia: a report from the Children's Cancer Group. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Right atrial thrombi in children with cancer and indwelling catheters. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Venous Thromboembolism in Pediatric Cancer Patients with Central Venous Catheter-A Systematic Review and Meta-analysis. [2022]