Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644599
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Wireless Monitoring for Clinical Deterioration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integrated Proactive Wireless Monitoring for Clinical Deterioration A Stepped Wedge Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
i-PROTECT
Brief Summary:
The study evaluates whether implementing a wireless monitoring system for patients admitted to hospital wards reduces mortality and cardiopulmonary failure
Detailed Description:
The trial is designed as a stepped-wedge cluster RCT Hospital wards which constitute clusters in this design will be randomized to have wireless monitoring 7 wards at a time with each 7 wards constituting a sequence The study consists of 5 periods of two-month sequences followed by a one-month transition time with a phased introduction of the intervention In the first period all wards will have no wireless monitoring After a baseline period of 2 1 washout months the intervention monitoring system will be implemented in a randomly selected new sequence every 3-month period until the intervention is implemented in all sequences
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