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NCT Number: NCT06289699

Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures

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.

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Key information

Conditions

User Experience Acute Medical Conditions Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie, Hamburg, Germany

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About this study

The participants will be monitored for 4 days postoperatively or for 4 days after acute admission and until discharge.

Monitoring devices used in this study will be validated FDA or/and CE approved devices used within their original purpose. Centers can choose to use Sotera Visimobile or Isansys Lifeguard with accompanying sensors. These devices will be used together with the CE approved WARD web and mobile application.

Study sites include: St. Olav Hospital Trondheim, Royal Liverpool University Hospital, University Medical Centre Hamburg-Eppendorf,University Medical Centre Groningen, The Netherlands and the Cleveland Clinic.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • RR < 11 breaths pr minute
  • Pulse (P) > 91 beats pr minute
  • Pulse (P) < 50 beats pr minute
  • SpO2 < 94 % without oxygen supplementation
  • Systolic BP < 110 mmHg
  • Systolic BP > 220 mmHg

Exclusion criteria

  • 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.

Treatment and study plan

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 months

Secondary outcomes

  1. Technical feasibility

    Time frame: during monitoring period, on average 3 months

    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.

  2. Alert relay to smartphones

    Time frame: during monitoring period, on average 3 months

    will be assessed by comparing % of alerts received compared to alerts generated by the WARD24/7 App.

  3. Response to alerts

    Time frame: during monitoring period, on average 3 months

    will be assessed using the response buttons as % of nurses pressing attend, snooze, or refer to colleague on the WARD24/7 App.

  4. Patients experiences from being monitored with wCSVM.

    Time frame: during monitoring period, on average 3 months

    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.

  5. Relevance of alarms

    Time frame: during monitoring period, on average 3 months

    by using feedback from the nurses given in the app, % of relevant alerts

  6. Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day

    Time frame: during monitoring period, on average 3 months

  7. Frequency of delivered alarms on respiration rate (RR) pr patient pr day

    Time frame: during monitoring period, on average 3 months

  8. Frequency of delivered alarms on heart rate (HR) pr patient pr day

    Time frame: during monitoring period, on average 3 months

  9. Frequency of delivered alarms on blod pressure (BP) pr patient pr day

    Time frame: during monitoring period, on average 3 months

  10. Overall score of user satisfaction from use of WARD24/7 app

    Time frame: during monitoring period, on average 3 months

    assessed by the mHealth App Usability Questionnaire (MAUQ) consisting of 18 items. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree.To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app.

  11. Subscale MAUQ scores

    Time frame: during monitoring period, on average 3 months

    assessed by the mHealth App Usability Questionnaire (MAUQ) consisting of 18 items. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree.To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app.

    Ease of use and satisfaction (5 items, MAUQ_E), system information arrangement (7 items, MAUQ_I), and usefulness (6 items, MAUQ_U).

  12. Monitoring practices prior to the wCVSM

    Time frame: Baseline, on average 3 months

    assessed by a semi structured interview guide including information on type of monitoring (manual/intermittent, type of vital signs collected, frequency of measurements, escalation protocols etc.).

Other outcomes

  1. Cumulative duration of SpO2<88% and SpO2 < 85%

    Time frame: during monitoring period, on average 3 months

  2. Cumulative duration of respiratory rate ≤ 5 min-1 and Respiratory rate > 24 min-1

    Time frame: during monitoring period, on average 3 months

  3. Cumulative duration of Heart rate > 130 min-1 and Heart rate ≤ 30 min-1

    Time frame: during monitoring period, on average 3 months

  4. Cumulative duration of Systolic blood pressure ≤ 90 mmHg and Systolic blood pressure > 220 mmHg o

    Time frame: during monitoring period, on average 3 months

  5. Cumulative duration of Circulatory failure

    Time frame: during monitoring period, on average 3 months

  6. Cumulative duration of Systolic blood pressure ≤ 90 mmHg AND Heart rate >110 min-1 OR heart rate < 50 bpm AND/OR SpO2 < 92% o

    Time frame: during monitoring period, on average 3 months

  7. Cumulative duration of Hypoventilation: RR < 11 AND SpO2 < 88%

    Time frame: during monitoring period, on average 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Eske Kvanner Aasvang, MD

CONTACT

[email protected]

Katja K Head of Clinical, MD

CONTACT

[email protected]

004528781188 ext. 004528781188

Sponsors and collaborators

Lead sponsor

Christian S. Meyhoff

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

Alert Frequency, Nurse, and Patient Satisfaction With a Continuous Wireless Vital Sign Monitoring Software Across Health Care Systems and Cultures

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2024
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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