Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04581031
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2020-05-04
Brief Title:
COntinuous Signs Monitoring In Covid-19 Patients
Sponsor:
The Christie NHS Foundation Trust
Organization:
The Christie NHS Foundation Trust
Study Overview
Official Title:
COntinuous Signs Monitoring In Covid-19 Patients
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COSMIC-19
Brief 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 patients 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
All data recorded from the wearable sensors in this study will be analysed in conjunction with routine data collected during the patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None