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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04724681
Other study ID # H-20025357
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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