Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04285775 |
| Other study ID # |
NHIC-I2D-1608124 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2019 |
| Est. completion date |
June 30, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Changi General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Background
Post-procedural wound hemorrhage is a potential complication following any invasive
procedure. In the setting of hemodialysis, with multiple repeated vascular access procedures
performed on uremic patients prone to bleeding, post-procedural bleeding would not be
infrequent.
Serious adverse events following central venous catheter removal, while rare, were not
isolated incidents. The British National Reporting and Learning System, reported 6 incidents
of late bleeding following femoral line removal over 3 years. Of these, 3 resulted in deaths
and 2 suffered more than one litre of blood loss. The UK Renal Association, British Renal
Society and Intensive Care Society subsequently released a recommendation for the safe
removal of a temporary femoral dialysis line in 2019. Protocols implemented in some units
required an intense period of monitoring every 5-15 minutes in the first 2 hours.
However, frequent monitoring protocols places additional demands on already scarce nursing
manpower. As catastrophic bleeding is rare, it is difficult to expect healthcare staff to
maintain a consistent high level of vigilance for such a low probability event. The
possibility of missed catastrophic bleeding is always present, particularly if the patient is
incapacitated and unable to call for assistance.
A technological solution to safely monitor patients for bleeding following catheter removal
is needed. Ideally, this technology should also be applicable for other wounds at risk of
severe bleeding, for example, after arterial access for coronary angiogram or vascular
interventions. There were no commercially available devices which fully met the user
requirements, which included ease of use, wireless, compact form factor and specific
detection of bleeding with no direct contact with the wound or blood. A compact device was
developed
Through a research collaboration between a hospital and a technology and design university,
supported by a national innovation grant, a device was developed to monitor wound for
bleeding. By the end of 2018, a working prototype - Blood Warning Technology with Continuous
Hemoglobin sensor (BWATCH) - was available for first-in-human clinical trials. The
technological concept has been presented in electrical engineering conferences. This is a
stand-alone disc-shaped device (approximately 5 cm in diameter and <1 cm thick) which can be
placed over dressings and continuous monitoring for bleeding will take place. The presence of
fresh blood triggers a loud alarm, alerting medical staff to attend to the patient.
Objectives
The primary aim of this clinical trial was to evaluate the sensitivity of the device in
detecting bleeding in a clinical environment. The secondary aim is to determine the
specificity of the device for actual bleeding (false positive rates).
Materials and Methods
This study has been reviewed and approved by the institutional review board (Singhealth cIRB
2014-2036).
This a prospective, observational study performed in an acute care hospital. Inpatients
planned for dialysis catheter insertion or removal based on standard clinical care and
indications will be identified fro recruitment.
Consent will be obtained from the patient or their legal representative if cognitively
impaired. As part of standard care, the procedurist will secure haemostasis following the
procedure and apply a bandage. The investigators will then place the device over the dressing
and secure it in place. The device will then be left in-situ for at least 6 hours. Any alarms
triggered and bleeding episodes will be documented in a case report form.
For safety, throughout the observation period, routine monitoring and inspection for bleeding
by the nurse-in-charge would continue as per hospital clinical protocol.
Baseline demographic data of the patients will be collected. Laboratory test results
collected will include the platelet count, international normalized ratio (INR) and partial
thromboplastin time (PTT). The use of any anti-coagulation or anti-platelet medication will
be recorded.
From the bleeding incidences and device alarm activation rates, the sensitivity and
specificity of the device for detection of true bleeding will be calculated.
