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.
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.
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.
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria
apply:
1. Adult (aged 16 years or older), hospital inpatients
2. Suspected or confirmed COVID-19 infection (nasopharyngeal swab sent or planned):
1. Positive nasopharyngeal swab during this admission OR
2. Nasopharyngeal swab pending during this admission and the treating team suspect
COVID-19 OR
3. Negative nasopharyngeal swab during this admission but the treating team continue
to suspect COVID-19 OR
4. Positive nasopharyngeal swab in the last 7 days
3. Emergency admission to hospital within the last 72 hours and/or a positive
nasopharyngeal test within the last 72 hours taken from a patient who was already an
inpatient at the time the swab was taken.
4. Symptoms consistent with COVID-19 infection at the time of admission or when swab
taken: cough, shortness of breath, alteration to sense of taste or smell, fevers or
other symptoms in keeping with COVID-19 in the opinion of the study team.
5. For full active treatment (including escalation to critical care)
6. The patient is at risk of deterioration (as evidenced by a requirement for
supplementary oxygen)
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
1. Patients unable to give informed consent.
2. Patients with a life expectancy of <24hours.
3. Known allergy or history of contact dermatitis to medical adhesives.
4. Patients with pacemakers, implantable defibrillators or neurostimulators.
5. Patients with an arterio-venous fistula in either arm.
The Christie NHS Foundation Trust
Manchester, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom