Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT02084394
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2014-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Blood Flow During CPB During Cardiac Surgery and the Presence of Post op Delirium
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Non Invasive Monitoring of Cerebral Blood Flow During and After Cardiopulmonary Bypass to Assess and Compare for the Presence of Delirium in Post Operative Patients (DELIRIUM)
Status:
COMPLETED
Status Verified Date:
2016-02
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:
Cardiac surgery is associated with multiple events and issues that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. The risk for postoperative delirium is generally thought to result from some previous health factors added to the susceptibility of the cardiac surgery process.
Detailed Description:
Cardiac surgery is associated with multiple perturbations that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. These same perturbations likely also increase the risk for postoperative delirium although there are little data that have evaluated this hypothesis.
As the subject is prepared for surgery 2 contact probes will be placed on the forehead to monitor the rSO2 and cerebral blood flow. This monitor can also measureblood flow velocity in blood vessels in the forehead.
This will only be done while the subject is on the cardiac bypass machine during the surgery and end shortly after entering the intensive care unit.Prior to surgery and then once a day on three of the first four postoperative days, patients will be assessed for the presence and severity of delirium with brief standard psychological exams. We will compare rSO2 and CBF changes between patients with and without delirium
As the subject is prepared for surgery 2 contact probes will be placed on the forehead to monitor the rSO2 and cerebral blood flow. This monitor can also measureblood flow velocity in blood vessels in the forehead.
This will only be done while the subject is on the cardiac bypass machine during the surgery and end shortly after entering the intensive care unit.Prior to surgery and then once a day on three of the first four postoperative days, patients will be assessed for the presence and severity of delirium with brief standard psychological exams. We will compare rSO2 and CBF changes between patients with and without delirium
Study Oversight
Has Oversight DMC:
False
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?: