NCT01737554

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cancer
• Hematologic Disorders

Interventions

Type	Name	Description
OTHER	Catheter Resistance Monitoring	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.

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2012-11-29
• Last updated: 2016-12-21

Locations

1 site across 1 country: United States