Clinical trial NCT04724681: Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection
Official title: Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Clinical Deterioration
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2021-01-26
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective controlled cohort study
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Cumulative duration of deviating vital signs: SpO2 < 85% min-1
timeFrame: up to 16 days
measure: Cumulative duration of deviating vital signs, respiratory rate ≤ 5 min-1
timeFrame: up to 16 days
measure: Cumulative duration of deviating vital signs, respiratory rate > 24 min-1
timeFrame: up to 16 days
measure: Cumulative duration of deviating vital signs, heart rate > 130 min-1
timeFrame: up to 16 days
measure: Cumulative duration of deviating vital signs, heart rate ≤ 30 min-1
timeFrame: up to 16 days
measure: Cumulative duration of deviating vital signs, ScO2
timeFrame: up to 16 days
Secondary outcomes:
measure: Frequency of predefined microevents (deviating vital signs)
timeFrame: up to 16 days
measure: Change in vital parameters
timeFrame: up to 16 days
measure: The frequency of events with desaturation as defined below and the simultaneous values of ScO2
timeFrame: up to 16 days
measure: Events with ScO2 < 60% for ≥ 1 min
timeFrame: up to 16 days
Other outcomes:
measure: Duration of vital sign deviation
timeFrame: up to 16 days
measure: ECG pattern after alarm
timeFrame: up to 16 days
measure: Adverse clinical ooutcomes
timeFrame: 6 months
measure: Response to an alarm
timeFrame: up to 16 days
measure: Contact to the attending doctor on call
timeFrame: up to 16 days
measure: Contact to intensive care physician on call
timeFrame: up to 16 days
measure: Activation of Emergency Response Team
timeFrame: up to 16 days
measure: Invasive ventilation
timeFrame: up to 16 days
measure: ICU admissions
timeFrame: up to 16 days
measure: Length of stay
timeFrame: up to 16 days
measure: Cumulative duration of ScO2 <60 % during admission
timeFrame: up to 16 days
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Katja Grønbæk, MD, PhD-student
role: PRINCIPAL_INVESTIGATOR
References: