NCT04315129

Smart Catheter: A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Urinary Tract Infection (UTI) is the most common hospital acquired infection worldwide, and is most commonly associated with catheterisation of the bladder. Catheter associated urinary tract infection (CAUTI) causes increased hospital costs, increased length of stay and increased mortality. This burden of disease is, in part, mediated by a lack of diagnostic and monitoring modalities for CAUTI. Both traditional and novel UTI diagnostic tests are susceptible to false positives associated with bacterial colonisation, and correlate poorly with clinically meaningful symptomatic CAUTI. As such, the current standard of care is reliant on clinical monitoring, which is susceptible to diagnostic delays, over and under treatment. Imperial College London have developed a wireless biosensor for continuous monitoring of catheter-urine biochemistry. This project aims to validate this biosensor and demonstrate it's potential for preemptive CAUTI diagnosis through continuous urinary biochemical monitoring.

Detailed description

This research project aims to demonstrate that continuous urinary biochemical monitoring using a Smart Catheter biosensor can provide rapid diagnosis of impending catheter associated urinary tract infection (CAUTI). The primary research question will then be: "Does the Smart Catheter device reduce the time to diagnosis of CAUTI?" This will be accomplished through four studies: The aim of the first study will be to show the reliability and robustness of the Smart Catheter device through the question: "Is there any difference between the biochemical measurements from the Smart catheter device and a gold-standard laboratory measurement?" The aim of the second and third studies aim to demonstrate the different biochemical profiles of infected and healthy urine by addressing the research question: "What is the difference in biochemical concentrations in healthy urine as compared to infected urine?" Study 3 will accomplish this by comparing infected human catheter-acquired urine as compared to uninfected human catheter-urine. Study 3 will monitor the changes in biochemical changes in an artifical bladder with artificial urine over time while an infection is induced. The final study will demonstrate the reduced time to diagnosis in a clinical setting by addressing the research question: " What is the time difference in diagnosis of CAUTI from the CAUTI as compared to the current standard of clinical monitoring?"

Conditions

• Catheter-Associated Urinary Tract Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Smart Catheter Biosensor	A novel biosensor in-built into the catheter drainage system that monitors the chemical composition of the urine, with the intention of providing early diagnosis of developing infection

Timeline

• Start date: 2018-04-01
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2020-03-19
• Last updated: 2021-09-02

Locations

1 site across 1 country: United Kingdom