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

NCT ID: NCT04724681

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2022-12-31

Brief Summary

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

Conditions

Clinical Deterioration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Monitoring arm

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

Group Type: ACTIVE_COMPARATOR

WARD CSS

Intervention Type: DEVICE

Wireless devices monitor vital signs continuously and transmit real-time data to an app that notifies clinical personnel when relevant deviations in vital signs occur This group will be monitored with standard Early Warning Score as well

standard Early Warning Score arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

WARD CSS

Wireless devices monitor vital signs continuously and transmit real-time data to an app that notifies clinical personnel when relevant deviations in vital signs occur This group will be monitored with standard Early Warning Score as well

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role: lead

Responsible Party

Katja Kjær Grønbæk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katja Grønbæk, MD, PhD-student

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

Bispebjerg and Frederiksberg Hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-20025357

Identifier Type: -

Identifier Source: org_study_id