Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161480
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-27
Brief Title:
Feasibility and Acceptability of Using Weighted Blankets to Prevent and or Mitigate Delirium
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
The Feasibility and Acceptability of Using Weighted Blankets to Prevent andor Mitigate Delirium in Adult Critical Care Patients in Urban and Rural Settings
Status:
RECRUITING
Status Verified Date:
2023-12
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 use of weighted blankets to avert or alleviate Delirium in Adult ICU patients
Detailed Description:
To examine the feasibility and acceptability of weighted blankets as a single component nonpharmacologic strategy to prevent andor mitigate delirium in an adult medicine critical care patient population To examine the feasibility and acceptability of videoconferencing VCU Health Zoom EHR screening and VCU and VCU Health infrastructure REDCap OnCore for rural participant recruitment and research participation remote HealthCare provider protocol training and research engagement and remote research monitoring and support for rural patient population To collect preliminary descriptive data and examine trends related to the use of weighted blankets to prevent andor mitigate delirium to inform future efficacy trials in an adult medicine critical care patient population eg Agitation Delirium ICU length of stay number ventilator days sedationopioid medication usage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None