Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-29 @ 3:16 PM
Study NCT ID:
NCT04559269
Status:
UNKNOWN
Last Update Posted:
2020-09-22
First Post:
2020-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Micro-sleep During Maintenance Wakefulness Tests
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
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:
During general anesthesia, intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Mean arterial pressure (MAP) \< 65mmHg is the most common definition of hypotension. In order to reduce IOH, a complex method using machine learning called hypotensive prediction index (HPI) was shown to be superior to changes in MAP (ΔMAP) to predict hypotension (MAP between 65 and 75 excluded). Linear extrapolation of MAP (LepMAP) is also very simple and could be a better approach than ΔMAP. The main objective of the present study was to investigate whether LepMAP could predict IOH during anesthesia 1, 2 or 5 minutes before.
Detailed Description:
Hypothesis : the area under the ROC curves (ROC AUCs) at 1, 2 and 5 minutes of LepMAP would be superior to AMAP
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?: