Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection (WARD COVID-19)

University Hospital Bispebjerg and Frederiksberg

Status: Terminated

Conditions: Clinical Deterioration

Treatments: Device: WARD CSS

Study type: Interventional

Funder types: Other

Identifiers

NCT04724681

H-20025357

Details and patient eligibility

About

For patients admitted with COVID-19 infection, it is often difficult to predict if or when their clinical condition will deteriorate. However subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. The primary aim of this study is to test the effect of continuous wireless vital signs monitoring with generation of real-time alerts through a purpose-built GUI, compared to standard EWS monitoring on the cumulative duration of any severely deviating vital signs

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Adult patients (≥18 years).
• Inclusion possible within 72 hours of admission, OR within 48 hours of discharge from an ICU to a medical ward
• At least one expected overnight stay.
• Patient admitted with confirmed COVID-19 infection

Exclusion criteria

• Patient expected not to cooperate with study procedures.
• Allergy to plaster or silicone.
• Patients admitted for palliative care only (i.e. no active treatment).
• Patients previously enrolled in the studies WARD-COPD (H-18026653) or WARD-Surgery (H-17033535).
• Inability to give informed consent.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Monitoring arm

Active Comparator group

Description:

Patients in this arm will have their vital signs monitored with continuous wireless devices and patients in this arm will be monitored with standard Early Warning Score

Treatment:

Device: WARD CSS

standard Early Warning Score arm

No Intervention group

Description:

Patients in this arm will be monitored with standard Early Warning Score