NCT04581031

COntinuous Signs Monitoring In Covid-19 Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: The Christie NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to assess whether artificial intelligence (AI) combined with continuous vital signs monitoring from wearable sensors can predict clinically relevant outcomes in patients with suspected or confirmed Covid-19 infection on general medical wards.

Detailed description

Adult patients on general medical wards with COVID-19 infection considered to be at high risk of deterioration will be asked to wear vital signs sensors for the duration of their hospital stay. These sensors are an established method of recording patient vital signs and are CE marked. Patients enrolled in the study will continue to receive routine medical care as directed by their treating team. All data recorded from the wearable sensors in this study will be analysed in conjunction with routine data collected during the patient's treatment. Several models will be created using deep learning AI techniques with the aim of reliably predicting several important clinical outcomes. The study will identify whether continuous monitoring alone can improve identification of deteriorating patients compared to traditional vital signs and if the addition of AI technology / algorithms can provide even earlier identification.

Conditions

• COVID-19

Interventions

Type	Name	Description
DEVICE	Continuous vital sign monitoring - Isansys Patient Status Engine	CE marked wearable continuous vital signs monitors
OTHER	Machine Learning/AI Algorithm	Patient data will be subjected to machine learning/AI algorithms to determine whether algorithms may be beneficial as an early indication of patient's condition worsening.

Timeline

• Start date: 2020-07-11
• Primary completion: 2022-04-22
• Completion: 2022-04-22
• First posted: 2020-10-09
• Last updated: 2022-05-27

Locations

2 sites across 1 country: United Kingdom