Status:
UNKNOWN
A New Securement Method for External Tunneled Central Venous Access Devices (CVAD)
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Children's Hospital Colorado
Conditions:
Central Venous Catheter Exit Site Infection
Central Venous Catheter Related Bloodstream Infection
Eligibility:
All Genders
31-18 years
Phase:
NA
Brief Summary
An external tunneled central venous access device (CVAD) is a small plastic tube that is tunneled under the skin into a major vein for long-term use (Figure 1). Patients who require a tunneled CVAD ar...
Detailed Description
A prospective pilot trial to examine the feasibility for a new CVAD securement device prototype (see appendix for computer-aided design drawings). Eligible patients will be identified by either mid-le...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04462861
Start Date
October 19 2020
End Date
June 1 2024
Last Update
June 15 2023
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 54008