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A device for surveillance of vascular access sites for bleeding: results from a clinical evaluation trial
Journal article   Open access   Peer reviewed

A device for surveillance of vascular access sites for bleeding: results from a clinical evaluation trial

Chang Yin Chionh, Desilyn Yuqing Soh, Chee How Tan, Jien-Yi Khaw, Ying Ching Wong, Shaohui Foong and CREMERE Group
Scientific reports, Vol.10(1), p.18153
23/10/2020
PMID: 33097747

Abstract

Aged False Negative Reactions Female Hemoglobins - analysis Humans Male Middle Aged Monitoring, Physiologic - instrumentation Patient Safety Postoperative Hemorrhage - diagnosis Postoperative Hemorrhage - etiology Predictive Value of Tests Prospective Studies Renal Dialysis - adverse effects Renal Dialysis - instrumentation Sensitivity and Specificity Vascular Access Devices - adverse effects
Post-procedural wound haemorrhage is a potentially life-threatening complication. For haemodialysis patients, bleeding is often encountered after vascular access procedures and fatal episodes have been reported. Visual monitoring for bleeding is manpower intensive and bleeding episodes may still be missed between inspections. A device, Blood WArning Technology with Continuous Haemoglobin sensor (BWATCH), was developed to detect bleeding from wounds. This a prospective, observational clinical trial on patients who have had a dialysis catheter inserted or removed. The battery-powered, disc-shaped device (43 mm diameter, 12 mm height) was placed over the dressing for at least six hours. The device detects reflected light with characteristics specific for haemoglobin and an alarm would be triggered if bleeding occurs. There were 250 participants (177 post-insertion, 73 post-removal) and 36 episodes of bleeding occurred. The device alarm was triggered in all instances but there were also 9 false alarms. Specificity was 95.8%, false positive rate was 4.2% and positive predictive value was 80.0%. Sensitivity and negative predictive value were 100% but detection failure may still occur due to improper application or device maintenance. The use of technological aids for monitoring improves patient safety and may reduce demand on manpower.
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https://doi.org/10.1038/s41598-020-74571-2View
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