Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents: A Feasibility Study

Conditions
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Cancer, Hematologic Disorders

Intervention / Treatment
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* Other: Catheter Resistance Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving treatment for any disease at St. Jude Children's Research Hospital (SJCRH). Age ≥5 years to <25 years. Participant is using either a single or double lumen tunneled CVAD (ports will not be eligible) as part of standard clinical care. Participant anticipates being present weekly at SJCRH for at least 12 weeks Exclusion Criteria: Plan to remove CVAD within 12 weeks. Expected survival less than 12 weeks Past enrollment in the CaRMA study or past catheter resistance monitoring

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>Participants include children with cancer and hematologic disorders who, as part of their standard clinical care, have a central venous access device (CVAD) used for infusion, withdrawal of blood, or hemodynamic monitoring. Intervention: Catheter resistance monitoring | Other: Catheter Resistance Monitoring<br>* 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.<br>* Other names: CRM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Weekly for 12 weeks from study entry or until discontinuation of CRM, whichever is shorter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central venous access device, Catheter resistance monitoring