Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574867
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Evaluation of the ViQtor Monitoring Solution on Surgical Wards
Sponsor:
None
Organization:
None
Study Overview
Official Title:
REQUEST - RemotE Monitoring by ViQtor Upon Implementation on a Surgical DepartmenT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REQUEST
Brief Summary:
The REQUEST study aims to evaluate the use of a new wireless monitoring device called the viQtor solution on a surgical ward in Catharina Hospital Eindhoven This device continuously tracks vital signs such as heart rate breathing rate and blood oxygen levels in patients after surgery The goal is to see if the viQtor solution can help detect health problems earlier and reduce the workload for nurses by minimizing the need for manual checks The study will involve 500 patients and will take place over 7 months
Detailed Description:
Detailed Description
This is a prospective implementation evaluation study of the viQtor solution a wearable medical device designed for continuous monitoring of vital signs in post-operative patients The study will be conducted at the Catharina Hospital Eindhoven on the surgical ward 5 Oost and will be divided into two phases each involving approximately 250 patients
In Phase 1 Months 1-3 patients will continue to receive standard care which includes manual spot checks and Modified Early Warning Score MEWS assessments by nursing staff During this phase healthcare professionals will receive training on how to use the viQtor solution
In the Evaluation and Validation Period Month 4 the accuracy of the viQtor device will be validated by comparing its continuous monitoring data with the manual measurements taken by nurses
In Phase 2 Months 5-7 the viQtor solution will become the primary method for monitoring patients with manual checks conducted only when necessary The study aims to assess the viQtor solutions usability acceptance adoption by healthcare professionals and its accuracy in detecting patient deterioration It will also evaluate the feasibility of implementing this technology in a real-world hospital setting and its impact on clinical outcomes
The viQtor solution is a CE-marked Class IIa medical device ensuring compliance with European safety standards It is designed to be worn on the upper arm and is capable of wirelessly transmitting data every five minutes to a cloud-based platform accessible to healthcare professionals
Participants in this study will include adult patients admitted to the surgical ward for various procedures The study will not only assess the technical performance of the viQtor solution but also its impact on the workflow and workload of healthcare providers
Data collected during the study will be used to determine the potential benefits and challenges of implementing continuous monitoring technology in hospital settings The ultimate goal is to improve patient safety and outcomes through early detection of health deterioration while also reducing the burden on nursing staff
If successful this study could pave the way for broader adoption of wearable monitoring technology in hospitals potentially setting a new standard of care for post-operative patients
This detailed description provides a comprehensive overview of the study objectives methodology and expected outcomes without duplicating information entered elsewhere in the record
This is a prospective implementation evaluation study of the viQtor solution a wearable medical device designed for continuous monitoring of vital signs in post-operative patients The study will be conducted at the Catharina Hospital Eindhoven on the surgical ward 5 Oost and will be divided into two phases each involving approximately 250 patients
In Phase 1 Months 1-3 patients will continue to receive standard care which includes manual spot checks and Modified Early Warning Score MEWS assessments by nursing staff During this phase healthcare professionals will receive training on how to use the viQtor solution
In the Evaluation and Validation Period Month 4 the accuracy of the viQtor device will be validated by comparing its continuous monitoring data with the manual measurements taken by nurses
In Phase 2 Months 5-7 the viQtor solution will become the primary method for monitoring patients with manual checks conducted only when necessary The study aims to assess the viQtor solutions usability acceptance adoption by healthcare professionals and its accuracy in detecting patient deterioration It will also evaluate the feasibility of implementing this technology in a real-world hospital setting and its impact on clinical outcomes
The viQtor solution is a CE-marked Class IIa medical device ensuring compliance with European safety standards It is designed to be worn on the upper arm and is capable of wirelessly transmitting data every five minutes to a cloud-based platform accessible to healthcare professionals
Participants in this study will include adult patients admitted to the surgical ward for various procedures The study will not only assess the technical performance of the viQtor solution but also its impact on the workflow and workload of healthcare providers
Data collected during the study will be used to determine the potential benefits and challenges of implementing continuous monitoring technology in hospital settings The ultimate goal is to improve patient safety and outcomes through early detection of health deterioration while also reducing the burden on nursing staff
If successful this study could pave the way for broader adoption of wearable monitoring technology in hospitals potentially setting a new standard of care for post-operative patients
This detailed description provides a comprehensive overview of the study objectives methodology and expected outcomes without duplicating information entered elsewhere in the record
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None