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

NCT04724681 | Terminated

• 1 other identifier: H-20025357
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Cumulative duration of deviating vital signs: SpO2 < 85% min-1

  Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● SpO2 \< 85% min-1

  up to 16 days

• Cumulative duration of deviating vital signs, respiratory rate ≤ 5 min-1

  Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Respiratory rate ≤ 5 min-1

  up to 16 days

• Cumulative duration of deviating vital signs, respiratory rate > 24 min-1

  Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Respiratory rate \> 24 min-1

  up to 16 days

• Cumulative duration of deviating vital signs, heart rate > 130 min-1

  Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Heart rate \> 130 min-1

  up to 16 days

• Cumulative duration of deviating vital signs, heart rate ≤ 30 min-1

  Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Heart rate ≤ 30 min-1

  up to 16 days

• Cumulative duration of deviating vital signs, ScO2

  Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Lowest ScO2 (mean for ≥ 5 mins) min-1

  up to 16 days

Secondary Outcomes (4)

• Frequency of predefined microevents (deviating vital signs)

  up to 16 days

• Change in vital parameters

  up to 16 days

• The frequency of events with desaturation as defined below and the simultaneous values of ScO2

  up to 16 days

• Events with ScO2 < 60% for ≥ 1 min

  up to 16 days

Other Outcomes (11)

• Duration of vital sign deviation

  up to 16 days

• ECG pattern after alarm

  up to 16 days

• Adverse clinical ooutcomes

  6 months

Study Arms (2)

Monitoring arm

ACTIVE COMPARATOR

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

Device: WARD CSS

standard Early Warning Score arm

NO INTERVENTION

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

Interventions

WARD CSS 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

Monitoring arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years).
• At least one expected overnight stay.
• Patient admitted with confirmed COVID-19 infection

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Bispebjerg and Frederiksberg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Katja Grønbæk, MD, PhD-student

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A prospective controlled cohort study

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: January 26, 2021
• Study Start: November 3, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

DK (1)