Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289699
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-01-22
Brief Title:
Alert Frequency Nurse and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures
Sponsor:
Christian S Meyhoff
Organization:
University Hospital Bispebjerg and Frederiksberg
Study Overview
Official Title:
Alert Frequency Nurse and Patient Satisfaction With a Continuous Wireless Vital Sign Monitoring Software Across Health Care Systems and Cultures
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 orand 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-EppendorfUniversity Medical Centre Groningen The Netherlands and the Cleveland Clinic
Monitoring devices used in this study will be validated FDA orand 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-EppendorfUniversity Medical Centre Groningen The Netherlands and the Cleveland Clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None