Catheter occlusion and dysfunction are common complications of central venous access device (CVAD) use in children with cancer and hematologic disorders. These events can lead to interruption of therapy and may require device removal and replacement. Attempts to clear occlusion can cause device fracture. There is a clear link between catheter occlusion and other serious complications including bloodstream infection and intravascular thrombosis. There is evidence that catheter occlusion or dysfunction may be preceded by subclinical catheter narrowing, which could be detected by accurate measurement of catheter resistance. This study aims to observe and describe the feasibility and results of catheter resistance monitoring (CRM) over time with the aim of prospectively identifying patients at high risk of catheter occlusion. If CRM is feasible and proves to be sensitive and specific, it could provide an opportunity for preemptive therapy to prevent occlusion, which might also prevent bloodstream infection or thrombosis.
Weekly measurement of catheter resistance will be determined using the Alaris® Syringe Module (Carefusion Inc., San Diego, USA), a commercially available, FDA-approved intravenous (IV) pump which is able to deliver accurate flow-rates and obtain accurate pressure measurements. The inline pressure will be measured at multiple flow-rates and resistance will be estimated from the gradient of the pressure-flow curve. Primary Objective * To describe the feasibility of weekly CRM in children and adolescents treated at St. Jude. Secondary Objectives * To describe patient and caregiver adherence with weekly CRM in children and adolescents treated at St. Jude. * To explore the correlation between results of CRM and catheter occlusion or dysfunction.
Study Type
OBSERVATIONAL
Enrollment
10
Weekly measurement of resistance to flow in the lumen(s) of a CVAD with the commercially available Alaris® Syringe Module IV pump. The aim is to identify an increase in resistance greater than normal variation. Inline pressure measurements will be recorded at multiple flow-rates and resistance will be estimated from the gradient of the pressure-flow curve.
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Proportion of attended CRM visits which produce usable resistance data for all lumens of the CVAD
To describe the feasibility of CRM in children and adolescents treated at St. Jude, the proportion of attended CRM visits which produce usable resistance data for all lumens of the CVAD will be recorded for each participant, and summary statistics, including median, range and standard deviation will be reported for the study population.
Time frame: Weekly for 12 weeks from study entry or until discontinuation of CRM, whichever is shorter
Attendance at each planned CRM visit
To describe patient and caregiver adherence with weekly CRM in children and adolescents treated at St. Jude, attendance at each planned CRM visit will be recorded. Summary statistics for proportion of planned visits attended for each participant, including median, range and standard deviation will be reported for the study population.
Time frame: Weekly for 12 weeks or until discontinuation of CRM for a prescribed reason, whichever is shorter
The relationship between CRM results and occlusion or dysfunction
To explore the correlation between the results of CRM and catheter occlusion or dysfunction in children and adolescents, the relationship between CRM results and occlusion or dysfunction will be described.
Time frame: Up to 15 weeks
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