Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Bispebjerg and Frederiksberg

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Vital signs measurements with new app

    Device

    Patients vital signs are monitored through an app for the nurses to use

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
30 days
2

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)).

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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