Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents: A Feasibility Study
5 Years
24 Years
Both
Cancer, Hematologic Disorders
Trial Information
Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents: A Feasibility Study
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.
Inclusion Criteria:
- Receiving treatment for any disease at St. Jude Children's Research Hospital (SJCRH).
- Age ≥5 years to <25 years.
- Single or double lumen tunneled CVAD (ports will not be eligible).
- 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Proportion of attended CRM visits which produce usable resistance data for all lumens of the CVAD
Outcome Description:
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.
Outcome Time Frame:
Weekly for 12 weeks from study entry or until discontinuation of CRM, whichever is shorter
Safety Issue:
No
Principal Investigator
Joshua Wolf, MBBS
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Institutional Review Board
Study ID:
CARMA
NCT ID:
NCT01737554
Start Date:
December 2012
Completion Date:
February 2015
Related Keywords:
- Cancer
- Hematologic Disorders
- Central venous access device
- Catheter resistance monitoring
- Hematologic Diseases
Name | Location |
|---|---|
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
