Continuous vital sign monitoring - Isansys Patient Status Engine
DeviceCE marked wearable continuous vital signs monitors
NCT Number: NCT04581031
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.
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Notify Me16 year and older
All sexes
Interventional
Not applicable
Manchester University NHS Foundation Trust, Manchester, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
CE marked wearable continuous vital signs monitors
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.
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
To investigate whether circadian rhythm disruption is involved in COVID-19
The Christie NHS Foundation Trust
Other
Acronym: COSMIC-19
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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