Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
Study NCT ID:
NCT05264766
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2022-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery
Sponsor:
Indonesia University
Organization:
Study Overview
Official Title:
The Use of Cooling Helmet for Neuroprotection Management in Patient Undergoing Open Heart Surgery: an Evaluation of Postoperative Neuron-specific Enolase (NSE) and Delirium
Status:
COMPLETED
Status Verified Date:
2022-03
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:
To know the relationship between the use of cooling helmet with the changes of NSE level and postoperative delirium event in open heart surgery
Detailed Description:
Subjects were assigned into two groups after giving consent to participate in the study using random allocation, 13 subjects per group. Blood sample from CVC were obtained to assess NSE preoperative. After induction, cooling helmet with circulating cold water were placed on patients group A and without circulating cold water on group B. Blood samples were obtain again 6 hours after cardiopulmonary bypass off to assess NSE postoperative. Delirium was assessed using Confusion Assessment Method - Intensive Care Unit (CAM-ICU)
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?: