WAVE. Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories

COVID Clinical Trial

— WAVE  

Official title:

Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories. The WAVE Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357834
• Other study ID #: WAVE
• Status: Completed
• Start date: October 22, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim is to develop a wearable-based ICU (intensive care unit) prediction algorithm for inpatients contracted with SARS-CoV-2. Inpatients with suspicion of COVID-19 or with confirmed SARS-CoV-2 infection will be included. The participants will be equipped with a smartwatch, which gathers physiological data throughout hospitalisation.

Description:

The SARS-CoV-2 pandemic puts an unprecedented burden on the healthcare system, specifically its healthcare providers and the resource demands for intensive care units (ICUs). To support effective care despite large case numbers, hospital operations urgently need improved decision support in early identification of patients at risk of an acute COVID-19 deterioration that requires ICU.

The investigators aim at developing a wearable-based ICU algorithm for inpatients contracted with SARS-CoV-2. Inpatients on the general ward with suspicion of COVID-19 or with confirmed SARS-CoV-2 infection will be included. The participant will be equipped with a smartwatch and wear the device throughout the hospital stay until the patient (1) is discharged home, (2) is transferred to the ICU, or (3) palliative care is initiated. The smartwatch collects several physiological parameters (e.g. heart rate, heart rate variability, respiration rate, oxygen saturation). The collected data will be used to develop an ICU prediction algorithm to detect patients at risk of an acute COVID-19 deterioration that requires ICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Informed consent as documented by signature

• Age >= 18 years

• Suspicion of COVID-19 or patient tested positive for SARS-CoV-2

• Hospitalisation on the general ward

Exclusion Criteria:

• Smartwatch cannot be attached around the wrist of the patient

• Direct transfer from the emergency department or external institution to ICU (i.e. no hospitalization on the general ward)

• Known allergies to components of the smartwatch

• Rejection of ICU transfer in the patient decree

Related Conditions & MeSH terms

• COVID
• COVID 19
• SARS-CoV 2

Intervention

Other:
• Equipment with smartwatch throughout hospital stay on the general ward
Participants with confirmed SARS-CoV-2 infection or suspicion of COVID-19 will be equipped with a smartwatch and wear the device throughout the hospital stay on the general ward.

Locations

Country	Name	City	State
Switzerland	Emergency Department, University Hospital Bern, Inselspital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	ETH Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of smartwatch data in predicting ICU requirement in COVID-19 contracted inpatients quantified as the area under the receiver operator characteristics curve (AUC ROC > 0.85).	Accuracy of the WAVE-model will be assessed using physiological data recorded by the smartwatch (Garmin vivoactive 4) during hospitalization complemented by demographic and health-related patient-information and will be analysed using applied machine learning technology for ICU prediction.	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Diagnostic accuracy of routine physiological data in predicting ICU requirement in COVID-19 contracted in-patients quantified as the area under the receiver operator characteristics curve (AUC ROC > 0.85).	Accuracy of the model will be assessed using physiological data routinely recorded during hospitalization and will be analysed using applied machine learning technology for ICU prediction.	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Diagnostic accuracy of predicting hospital discharge without ICU admission in COVID-19 contracted in-patients quantified as area under the receiver operator characteristics curve	Accuracy of the model will be assessed using data on comorbidities, medication treatment during hospitalization and physiological data and will be analysed using casual machine-learning approaches	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of heart rate from baseline (hospitalization) to ICU admission	Heart rate will be recorded throughout the hospitalization using a smartwatch (Garmin vivoactive 4S) and using routine medical monitors.	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of heart rate variability from baseline (hospitalization) to ICU admission	Heart rate variability will be recorded throughout the hospitalization using a smartwatch (Garmin vivoactive 4S)	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of skin temperature from baseline (hospitalization) to ICU admission	Skin temperature will be recorded throughout the hospitalization using a smartwatch (Garmin vivoactive 4S)	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of blood oxygen saturation from baseline (hospitalization) to ICU admission	Blood oxygen saturation will be recorded throughout the hospitalization using a smartwatch (Garmin vivoactive 4S) and using routine medical monitors	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of respiration rate from baseline (hospitalization) to ICU admission	Respiration rate will be recorded throughout the hospitalization using a smartwatch (Garmin vivoactive 4S) and using routine medical monitors	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of physical activity from baseline (hospitalization) to ICU admission	Physical activity will be recorded throughout the hospitalization using a smartwatch (Garmin vivoactive 4S)	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of stress level from baseline (hospitalization) to ICU admission	Stress level will be recorded throughout the hospitalization using a smartwatch (Garmin vivoactive 4S)	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of sleep pattern from baseline (hospitalization) to ICU admission	Sleep will be recorded throughout the hospitalization using a smartwatch (Garmin vivoactive 4S)	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of steps per day from baseline (hospitalization) to ICU admission	Steps per day will be recorded throughout the hospitalization using a smartwatch (Garmin vivoactive 4S)	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of systolic blood pressure from baseline (hospitalization) to ICU admission	Systolic blood pressure will be recorded throughout the hospitalization using a smartwatch (Garmin vivoactive 4S) and using routine medical monitors	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of diastolic blood pressure from baseline (hospitalization) to ICU admission	Diastolic blood pressure will be recorded throughout the hospitalization using a smartwatch (Garmin vivoactive 4S) and using routine medical monitors	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of body temperature from baseline (hospitalization) to ICU admission	Body temperature will be recorded throughout the hospitalization using a routine medical thermometer	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of oxygen partial pressure (pO2) from baseline (hospitalization) to ICU admission	Oxygen partial pressure (pO2) will be routinely assessed during the hospitalization in arterial or venous blood gas analyses	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of CO2 partial pressure (pCO2) from baseline (hospitalization) to ICU admission	CO2 partial pressure (pCO2) will be routinely assessed during the hospitalization in arterial or venous blood gas analyses	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of blood pH from baseline (hospitalization) to ICU admission	Blood pH will be routinely assessed during the hospitalization in arterial or venous blood gas analyses	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of bicarbonate from baseline (hospitalization) to ICU admission	Bicarbonate will be routinely assessed during the hospitalization in arterial or venous blood gas analyses	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of base excess from baseline (hospitalization) to ICU admission	Base excess will be routinely assessed during the hospitalization in arterial or venous blood gas analyses	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Secondary	Change of oxygen flow rate from baseline (hospitalization) to ICU admission	Oxygen flow rate will be routinely assessed during the hospitalization	until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)