Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: User Experience, Postoperative Complications, Acute Medical Conditions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany, Netherlands, Norway, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Alert Frequency, Nurse, and Patient Satisfaction With a Continuous Wireless Vital Sign Monitoring Software Across Health Care Systems and Cultures
Overview
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.
Detailed description
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.
Primary outcome measures
- 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 outcome measures (12)
- Technical feasibility [Time frame: during monitoring period, on average 3 months]
- Alert relay to smartphones [Time frame: during monitoring period, on average 3 months]
- Response to alerts [Time frame: during monitoring period, on average 3 months]
- Patients experiences from being monitored with wCSVM. [Time frame: during monitoring period, on average 3 months]
- Relevance of alarms [Time frame: during monitoring period, on average 3 months]
- Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day [Time frame: during monitoring period, on average 3 months]
- Frequency of delivered alarms on respiration rate (RR) pr patient pr day [Time frame: during monitoring period, on average 3 months]
- Frequency of delivered alarms on heart rate (HR) pr patient pr day [Time frame: during monitoring period, on average 3 months]
- Frequency of delivered alarms on blod pressure (BP) pr patient pr day [Time frame: during monitoring period, on average 3 months]
- Overall score of user satisfaction from use of WARD24/7 app [Time frame: during monitoring period, on average 3 months]
- Subscale MAUQ scores [Time frame: during monitoring period, on average 3 months]
- Monitoring practices prior to the wCVSM [Time frame: Baseline, on average 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- The Cleveland Clinic Foundation, General Anesthesiology — Cleveland
Germany · 1 center
- Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedi — Hamburg
Netherlands · 1 center
- University Medical Center Groningen, Department of Anesthesiology — Groningen
Norway · 1 center
- St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin — Trondheim
United Kingdom · 1 center
- Liverpool University Hospitals NHS Foundation Trust — Liverpool
Identifiers
NCT: NCT06289699 · WARD-CSS international 1251