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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data | during monitoring period, on average 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during monitoring period, on average 3 months |
| Alert relay to smartphones |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative duration of SpO2<88% and SpO2 < 85% | during monitoring period, on average 3 months | |
| Cumulative duration of respiratory rate ≤ 5 min-1 and Respiratory rate > 24 min-1 | during monitoring period, on average 3 months |
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
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katja K Head of Clinical, MD | Contact | 004528781188 | 004528781188 | katja.groenbaek@ward247.com |
| Eske Kvanner Aasvang, MD | Contact | Eske.Kvanner.Aasvang.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Christian S Meyhoff, MD, PhD | Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark | Principal Investigator |
| Eske K Aasvang, MD, DMSci | Rigshospitalet, Copenhagen University, Copenhagen, Denmark |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic Foundation, General Anesthesiology | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
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will be assessed by comparing % of alerts received compared to alerts generated by the WARD24/7 App.
| during monitoring period, on average 3 months |
| 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. | during monitoring period, on average 3 months |
| 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. | during monitoring period, on average 3 months |
| Relevance of alarms | by using feedback from the nurses given in the app, % of relevant alerts | during monitoring period, on average 3 months |
| Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day | during monitoring period, on average 3 months |
| Frequency of delivered alarms on respiration rate (RR) pr patient pr day | during monitoring period, on average 3 months |
| Frequency of delivered alarms on heart rate (HR) pr patient pr day | during monitoring period, on average 3 months |
| Frequency of delivered alarms on blod pressure (BP) pr patient pr day | during monitoring period, on average 3 months |
| Overall score of user satisfaction from use of WARD24/7 app | 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. | during monitoring period, on average 3 months |
| Subscale MAUQ scores | 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). | during monitoring period, on average 3 months |
| Monitoring practices prior to the wCVSM | 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.). | Baseline, on average 3 months |
| Cumulative duration of Heart rate > 130 min-1 and Heart rate ≤ 30 min-1 | during monitoring period, on average 3 months |
| Cumulative duration of Systolic blood pressure ≤ 90 mmHg and Systolic blood pressure > 220 mmHg o | during monitoring period, on average 3 months |
| Cumulative duration of Circulatory failure | during monitoring period, on average 3 months |
| Cumulative duration of Systolic blood pressure ≤ 90 mmHg AND Heart rate >110 min-1 OR heart rate < 50 bpm AND/OR SpO2 < 92% o | during monitoring period, on average 3 months |
| Cumulative duration of Hypoventilation: RR < 11 AND SpO2 < 88% | during monitoring period, on average 3 months |
| Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie | Completed | Hamburg | 20246 | Germany |
| University Medical Center Groningen, Department of Anesthesiology | Recruiting | Groningen | 9700 | Netherlands |
|
| St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin | Completed | Trondheim | 7006 | Norway |
| Liverpool University Hospitals NHS Foundation Trust | Not yet recruiting | Liverpool | L7 8YE | United Kingdom |
|
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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