New securement method for central venous access devices
A New Securement Method for External Tunneled Central Venous Access Devices (CVAD)
This study is testing a new securement device for central venous access in kids to see if it can help reduce infections and other problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 31 Days to 18 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04462861 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a new securement device for external tunneled central venous access devices (CVAD) aimed at reducing complications such as infections and catheter failures in pediatric patients. The study will enroll patients aged 31 days to 18 years who require a tunneled CVAD, and caregivers will be educated on how to use the device. Follow-up interviews will assess the device's performance, including comfort, ease of use, and any adverse events. The goal is to improve the safety and effectiveness of CVADs in vulnerable patient populations.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients aged 31 days to 18 years who require surgical placement of a tunneled CVAD.
Not a fit: Patients who are unable to provide consent or have impaired decision-making capacity will not benefit from this study.
Why it matters
Potential benefit: If successful, this new securement method could significantly reduce the risk of infections and complications associated with CVADs in pediatric patients.
How similar studies have performed: While similar approaches have been explored, this specific securement method is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 31 days to 18 years old, who will undergo surgical placement of a tunneled CVAD * Any patient with a pre-existing CVAD, who presents to the surgery clinic, emergency department, or is seen as an inpatient consult relating to complications associated with their CVAD * Patients admitted to the hospital with a pre-existing CVAD for reasons unrelated to the CVAD will be eligible for the study Exclusion Criteria: * Any assenting child or consenting parent/guardian can at any time refuse to participate in the study and will be removed * Any patient whose parents or legal guardians cannot be reached in person or by telephone to provide consent * Any prisoners, pregnant women, or person with impaired decision-making capacity
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Steven L Moulton, MD — Children's Hospital Colorado
- Study coordinator: Jenny Stevens, MD
- Email: jenny.stevens@childrenscolorado.org
- Phone: 2515899950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.