NCT04628858

Wireless Assessment of Respiratory and Circulatory Distress in Vascular Surgical Patients - An Observational Study

Continuous Monitoring of Physiological Parameters for Early Detection of Complications in Postoperative Vascular Surgical Patients - An Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Eske Kvanner Aasvang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Vascular postsurgical patients have a high risk of morbidity and mortality. On top of that, patients undergoing vascular surgery usually have a high burden of comorbidities. After a short stay in the post-operative ward, patients are usually transferred to a standard surgical ward. Monitoring of physiological parameters by intermittent manual recordings 8-12 hours apart, is today's standard of care in hospitals. However, no effect on length of hospital stay, morbidity or mortality has been proven. This may be due to the up to 12 hours of unobserved time that can occur, where physiological deviations can progress resulting in clinical adverse outcomes such as myocardial infarction or stroke. Vital sign micro events are occurrences when patient physiological parameters deviates significantly from what can be understood as normal physiology. Since adverse outcomes in patients rarely happens without deviating physiological parameters, it is to be investigated if micro events can be used to predict clinical adverse outcomes to patients. We acknowledge that during the observation period, the number of false alarms should be kept to a minimum to avoid the risk of 'alarm fatigue'

Conditions

• Complication of Surgical Procedure
• Complication of Anesthesia
• Respiratory Complication
• Circulatory; Complications

Timeline

• Start date: 2020-08-17
• Primary completion: 2021-01-23
• Completion: 2021-07-23
• First posted: 2020-11-16
• Last updated: 2022-04-27

Locations

1 site across 1 country: Denmark