WARD International Pilot Studies
Study design
This study will be an international multicentre prospective observational pilot study assessing the functionality and user experience of a new vital sign monitoring system.
Sample size
Each site can include up to 20 patients during the 3-month study period.
Study Sites
The Cleveland Clinic, Ohio, USA
University Medical Center Hamburg-Eppendorf, Germany
The Royal Liverpool University Hospital, UK
Skt. Olav Hospital Trondheim, Norway
University Medical Centre Groningen, The Netherlands
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
- RF >21 breaths pr minute
- RF < 11 breaths pr minute
- P > 91 beats pr minute
- P < 50 beats pr minute
- SpO2 < 94 % without oxygen supplementation
- Systolic BP < 110 mmHg
- Systolic BP > 220 mmHg
Study Procedures
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.
Outcome
Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data
Primary Investigators
Professor Daniel Sessler, MD (The Cleveland Clinic, Ohio, USA)
Professor Bernd Saugel, MD, Dr. Med. (University Medical Center Hamburg-Eppendorf, Germany)
Professor Ingeborg Welters, Dr. Med. (The Royal Liverpool University Hospital, UK)
Erlend Skraastad, MD, PhD (Skt. Olav Hospital Trondheim, Norway)
Dr. M.E. Havemann, Technical Physician (University Medical Centre Groningen, The Netherlands)
NCT: