Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChristian S. Meyhoff
About this trial
The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years)
Expected stay in the hospital ≥2 days
Admitted for surgery with expected duration of surgery >2 hours or admitted for acute medical condition with at least one of the following vital sign deviations within 24 hours of acute admission, recorded by the staff
RR > 21 breaths pr minute
Disqualifiers
Participant expected not to cooperate with study procedures.
Allergy to plaster or silicone.
Pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
Inability to give informed consent.
Trial population
20 Patients in the general ward (surgical or medical) will be monitored with wCVSM and answer a questionnaire afterwards. 20 nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift (including a shift where monitoring is initiated or a shift where the patient is discharged). Therefore, multiple nurses can be interviewed per patient. Patients will in addition have vital signs monitored as per standard practice. Participants will be recruited from wards at the study sites.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data
Time frame
during monitoring period, on average 3 monthsSecondary outcomes
1
Technical feasibility
will be assessed as data capture of vital signs as percentage of data from each of the vital sign sensors of the total monitoring period.
Time frame
during monitoring period, on average 3 months2
Alert relay to smartphones
will be assessed by comparing % of alerts received compared to alerts generated by the WARD24/7 App.
Time frame
during monitoring period, on average 3 months3
Response to alerts
will be assessed using the response buttons as % of nurses pressing attend, snooze, or refer to colleague on the WARD24/7 App.
Time frame
during monitoring period, on average 3 months4
Patients experiences from being monitored with wCSVM.
will be assessed by a questionnaire named "Patient experience with wireless vital sign monitorering" consisting of 8 items. Each item can be answered with: strongly agree, agree, neither agree nor disagree, disagree, and strongly disagree.
Time frame
during monitoring period, on average 3 monthsOther outcomes
1
Cumulative duration of SpO2<88% and SpO2 < 85%
Time frame
during monitoring period, on average 3 months2
Cumulative duration of respiratory rate ≤ 5 min-1 and Respiratory rate > 24 min-1
Time frame
during monitoring period, on average 3 months3
Cumulative duration of Heart rate > 130 min-1 and Heart rate ≤ 30 min-1
Time frame
during monitoring period, on average 3 months4
Cumulative duration of Systolic blood pressure ≤ 90 mmHg and Systolic blood pressure > 220 mmHg o
Time frame
during monitoring period, on average 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Christian S. Meyhoff
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Sponsor institution
Rigshospitalet, Denmark
Collaborator
Source ClinicalTrials.gov