About this trial
The primary aim of this study is to test and assess the implementation and effectiveness of continuous wireless vital signs monitoring with real-time alerts on:
The frequency of patients monitored with adequate data quality as adequate clinical user satisfaction in the initial versus the last part of the trial (primary outcome).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult participants (≥18 years)
Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration and being either at home (with no apparent need for hospitalization), and/or in hospital OR
Patients at either at home before, in-hospital and/or after hospitalization for elective major surgery, defined as surgery lasting more than one hour under general- or regional anaesthesia
Disqualifiers
The participant expected not to cooperate with study procedures.
Allergy to plaster or silicone.
Having pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
Inability to give informed consent.
Trial population
Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration and being either at home (with no apparent need for hospitalization), and/or in hospital OR Patients at either at home before, in-hospital and/or after hospitalization for elective major surgery, defined as surgery lasting more than one hour under general- or regional anaesthesia
Trial design
Other
Prospective
Treatments tested in this trial
Vital signs measurements with new app
DevicePatients vital signs are monitored through an app for the nurses to use
Treatment groups
Trial outcomes
Primary outcomes
Data quality
The number (frequency) of patients having adequate data quality (defined as at least 60% of the monitoring time with simultaneous recording of SpO2, respiratory rate, heart rate)
user satisfaction
Number of users with adequate clinical user satisfaction (defined as the nurse in charge of the patient at the end of monitoring answers "Agree" or "Strongly agree" to the question "WARD-monitoring was beneficial for monitoring of vital signs in this patientparticipant (response options: Strongly Disagree - Disagree - Neutral - Agree - Strongly Agree)).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Bispebjerg and Frederiksberg
Lead sponsor
Rigshospitalet, Denmark
Collaborator