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

Clinical Deterioration Clinical Trial

— WARD COVID-19  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04724681
• Other study ID #: H-20025357
• Status: Terminated
• Phase: N/A
• Start date: November 3, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Deterioration

Intervention

Device:
• 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

Locations

Country	Name	City	State
Denmark	Bispebjerg and Frederiksberg Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of vital sign deviation	Duration of each of the following vital sign deviations; SpO2 < 85%; Respiratory rate = 5 min-1; Respiratory rate > 24 min-1; Heart rate > 130 min-1; Heart rate = 30 min-1; Lowest ScO2 (mean for = 5 mins)	up to 16 days
Other	ECG pattern after alarm	ECG pattern one hour following an AFLI alarm. (analysed with paired statistics within the continuously monitored group). The ECG pattern one hour following an alarm can be classified as either normal sinusrythm or AFLI	up to 16 days
Other	Adverse clinical ooutcomes	Any adverse clinical outcomes as defined in the protocol	6 months
Other	Response to an alarm	Staff response time to an alarm (stratified according to time of day)	up to 16 days
Other	Contact to the attending doctor on call	number of times that the attending doctor on call is contacted during admission	up to 16 days
Other	Contact to intensive care physician on call	number of times that the intensive care physician on call is contacted during admission	up to 16 days
Other	Activation of Emergency Response Team	number of times that the Emergency Response Teams is activated during admission	up to 16 days
Other	Invasive ventilation	The frequency of invasive ventilation during admission	up to 16 days
Other	ICU admissions	The frequency of ICU admissions during admission	up to 16 days
Other	Length of stay	Length of stay (LOS) in days	up to 16 days
Other	Cumulative duration of ScO2 <60 % during admission	Cumulative duration of ScO2 < 60 % related to the total time of NIRS monitoring	up to 16 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Frequency of predefined microevents (deviating vital signs)	The frequency of micro events (deviating vital signs), measured by continuous vital sign monitoring and as measured by EWS in the control group; The microevents are defined as follows, and the the outcome are frequency of these; RR =5 bpm AND HR >20 bpm; RR =24 bpm; RR <11 bpm AND SpO2 <88 %; SpO2 <80%; SpO2 <85%; SpO2 <88%; SpO2 <92%; HR >130 bpm; HR =111 bpm; HR <30 bpm; HR = 30-40 bpm; Atrialflutter	up to 16 days
Secondary	Change in vital parameters	Change in vital parameters one hour following an alarm as defined below; Desaturation; • Change in SpO2 60 minutes after an alarm has been triggered. (SpO2 < 85 % for more than 5 minutes, SpO2 < 80 % for more than 1 minutes, SpO2 < 88 % for more than 10 minutes ); Tachypnea; • Change in RR 60 minutes after an alarm has been triggered. (RR >24 bpm for more than 5 minutes); Bradypnea/apnea • Change in RR and HR 60 minutes after an alarm has been triggered (RR =5 bpm AND HR >20 bpm for more than one minute); Hypoventilation • Change in RR and SpO2 60 minutes after an alarm has been triggered. (RR <11 bpm AND SpO2 <88% for more than 5 minutes ); Tachycardia; • Change in HR 60 minutes after an alarm has been triggered. (HR >130 for more than 30 minutes, HR >111 for more than 60 minutes); Bradycardia; • Change in HR 60 minutes after an alarm has been triggered. (HR <30 bpm for more than 1 minutes, HR 30-40 bpm for more than 5 minutes)	up to 16 days
Secondary	The frequency of events with desaturation as defined below and the simultaneous values of ScO2	The frequency of events with desaturation as defined below and the simultaneous values of ScO2; SpO2 <80% >1 min; SpO2 <85% > 5 min; SpO2 <88% > 10 min; SpO2 <92% > 60 min	up to 16 days
Secondary	Events with ScO2 < 60% for = 1 min	The frequency of events with ScO2 < 60% for = 1 min and the simultaneous measured SpO2 values	up to 16 days