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A Novel Device for Surveillance of Vascular Access Sites for Bleeding

NCT04285775 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2021-01-28

No results posted yet for this study

Summary

Background Bleeding is often encountered after vascular access procedures for dialysis and fatal episodes of haemorrhage has been reported. A technological solution was sought to monitor for such rare but potentially catastrophic incidents. A novel device, BWATCH, was developed to detect fresh blood from wounds.

Aims The aim of this clinical trial was to evaluate the sensitivity and specificity of the device in detecting bleeding in a clinical environment.

Methods This a prospective, observational study on inpatients who will have a dialysis catheter inserted or removed. The device will be placed over the dressing for at least 6 hours. An alarm will be triggered if the device detects moisture and wavelength of light reflected specific for haemoglobin.

Conditions

  • Dialysis; Complications
  • Wound Complication
  • Catheter Complications
  • Hemorrhage
  • Bleeding Wound

Interventions

DEVICE

Application of device which monitors for bleeding - Blood Warning Technology with Continuous Hemoglobin sensor (BWATCH)

A stand-alone disc-shaped device (approximately 5 cm in diameter and \<1 cm thick) which can be placed over dressings. Once switched on and put in place, continuous monitoring for bleeding takes place. Detection occurs in 2 phases. First, the system monitors for the appearance of fluid in the dressing by detecting a change in capacitance. Next, a light sensor differentiates blood from other fluids by detecting that a unique spectrum of light (525nm) is absorbed, a property unique for hemoglobin. The presence of fresh blood triggers a loud alarm, alerting medical staff to attend to the patient. The device can be used over transparent plastic dressings and does not require direct contact with blood.

Sponsors & Collaborators

  • Changi General Hospital

    lead OTHER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Singapore

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285775 on ClinicalTrials.gov