Clinical trial NCT06289699: Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures
Official title: Alert Frequency, Nurse, and Patient Satisfaction With a Continuous Wireless Vital Sign Monitoring Software Across Health Care Systems and Cultures
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: User Experience
Postoperative Complications
Acute Medical Conditions
Keywords: continuous wireless vital sign monitoring
vital sign deviation
healthcare system and culture
User Experience
Postoperative Complications
Acute Medical Conditions
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2024-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

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.

Primary outcomes:
measure: Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data
timeFrame: during monitoring period, on average 3 months
Secondary outcomes:
measure: Technical feasibility
timeFrame: during monitoring period, on average 3 months
measure: Alert relay to smartphones
timeFrame: during monitoring period, on average 3 months
measure: Response to alerts
timeFrame: during monitoring period, on average 3 months
measure: Patients experiences from being monitored with wCSVM.
timeFrame: during monitoring period, on average 3 months
measure: Relevance of alarms
timeFrame: during monitoring period, on average 3 months
measure: Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day
timeFrame: during monitoring period, on average 3 months
measure: Frequency of delivered alarms on respiration rate (RR) pr patient pr day
timeFrame: during monitoring period, on average 3 months
measure: Frequency of delivered alarms on heart rate (HR) pr patient pr day
timeFrame: during monitoring period, on average 3 months
measure: Frequency of delivered alarms on blod pressure (BP) pr patient pr day
timeFrame: during monitoring period, on average 3 months
measure: Overall score of user satisfaction from use of WARD24/7 app
timeFrame: during monitoring period, on average 3 months
measure: Subscale MAUQ scores
timeFrame: during monitoring period, on average 3 months
measure: Monitoring practices prior to the wCVSM
timeFrame: Baseline, on average 3 months
Other outcomes:
measure: Cumulative duration of SpO2<88% and SpO2 < 85%
timeFrame: during monitoring period, on average 3 months
measure: Cumulative duration of respiratory rate ≤ 5 min-1 and Respiratory rate > 24 min-1
timeFrame: during monitoring period, on average 3 months
measure: Cumulative duration of Heart rate > 130 min-1 and Heart rate ≤ 30 min-1
timeFrame: during monitoring period, on average 3 months
measure: Cumulative duration of Systolic blood pressure ≤ 90 mmHg and Systolic blood pressure > 220 mmHg o
timeFrame: during monitoring period, on average 3 months
measure: Cumulative duration of Circulatory failure
timeFrame: during monitoring period, on average 3 months
measure: Cumulative duration of Systolic blood pressure ≤ 90 mmHg AND Heart rate >110 min-1 OR heart rate < 50 bpm AND/OR SpO2 < 92% o
timeFrame: during monitoring period, on average 3 months
measure: Cumulative duration of Hypoventilation: RR < 11 AND SpO2 < 88%
timeFrame: during monitoring period, on average 3 months
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation, General Anesthesiology
state: Ohio
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie
city: Groningen
country: Netherlands
facility: University Medical Center Groningen, Department of Anesthesiology
city: Trondheim
country: Norway
facility: St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
Study officials:
affiliation: Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark
name: Christian S Meyhoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Copenhagen University, Copenhagen, Denmark
name: Eske K Aasvang, MD, DMSci
role: PRINCIPAL_INVESTIGATOR
References: