A Novel Device for Surveillance of Vascular Access Sites for Bleeding

NCT04285775 | Completed

• 1 other identifier: NHIC-I2D-1608124
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dialysis; Catheter; Access; Bleeding; Haemorrhage; Mortality; Monitoring; Detection

Outcome Measures

Primary Outcomes (1)

• Number of bleeding events detected by device

  Number of bleeding episodes and detected by the device

  0 to 6 hours after procedure

Secondary Outcomes (2)

• Number of False Alarms

  0 till 6 hours after procedure or till alarm triggered (whichever is earlier)

• Number of Missed Bleeding Events

  0 to 6 hours after procedure

Study Arms (2)

Insertion of Dialysis Catheter

Hospital inpatients planned for dialysis catheter insertion, based on standard clinical care and indications as identified by the primary nephrologist-in-charge.

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

Removal of Dialysis Catheter

Hospital inpatients planned for dialysis catheter removal, based on standard clinical care and indications as identified by the primary nephrologist-in-charge.

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

Interventions

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

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.

Insertion of Dialysis Catheter; Removal of Dialysis Catheter

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to an acute care hospital with renal failure requiring dialysis. These patients were planned for dialysis catheter insertion or removal, based on standard clinical care and indications as identified by the primary nephrologist-in-charge.

You may qualify if:

• Hospital inpatients planned for dialysis catheter insertion or removal, based on standard clinical care and indications as identified by the primary nephrologist-in-charge.

You may not qualify if:

• Patients who declined participation, or
• Patients with no legal representatives who were unable to provide consent

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Links

• The Renal Association, British Renal Society, Intensive Care Society. Patient Safety Alert: response to reported death from blood loss following removal of a temporary femoral dialysis catheter. Nov 29, 2018 \[cited Feb 01, 2020\].
• The Renal Association, British Renal Society, Intensive Care Society. Recommendation for the safe removal of a temporary femoral dialysis line. May 31, 2019 \[cited Feb 01, 2020\].

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: March 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)