Ignite Creation Date:
2024-05-06 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05101278
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-04-28
First Post:
2021-10-06
Brief Title:
ROS in TBI Patients in Relation to Level of Oxygenation
Sponsor:
Region Stockholm
Organization:
Region Stockholm
Study Overview
Official Title:
Formation of Reactive Oxygen Species in Patients With Severe Traumatic Brain Injury in Normal vs Increased Oxygenation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-04
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:
ROS-TBI
Brief Summary:
This project an observational study performed on patients with severe Traumatic Brain Injury TBI treated at Neurosurgical ICU NICU at Karolinska University Hospital The purpose of this study is to evaluate the effects of various oxygenation levels on production rate of Reactive Oxygen Species ROS in patients with severe traumatic brain injury TBI The patients will be included in the study after the placement of intracranial monitoring device consisting of intracranial pressure gage Codman microdialysis MD and Licox oxygen electrode for measurement of partial pressure of oxygen in brain tissue pBtO2 Intracranial monitoring is inserted on clinical indications and is used for early detection of deleterious processes in brain tissue such as hypoxia or hypoperfusion and for purpose of guiding of given therapies such as cerebral perfusion pressure CPP oxygenation dosage of vasoactive drugs etc Despite the technical possibilities to monitor all these physiological parameters there are no clear guidelines how to interpret the MD and pBtO2 data and implement it in clinical decision making One of the controversies deals with optimization of oxygen levels some authors point out the importance of adequate brain tissue oxygenation whereas other researchers are worried about the possible negative effects of excessive oxygen levels such as increased production of ROS or facilitating pulmonary atelectasis contributing to adverse outcome
The purpose of this study is to investigate the effect of various oxygenation levels on ROS production in TBI patients
This pilot study is designed to measure short-lived ROS in blood and microdialysis fluid samples of TBI patients during alternating periods of normal vs temporarily increased oxygenation levels under normobaric conditions normal atmospheric pressure
The purpose of this study is to investigate the effect of various oxygenation levels on ROS production in TBI patients
This pilot study is designed to measure short-lived ROS in blood and microdialysis fluid samples of TBI patients during alternating periods of normal vs temporarily increased oxygenation levels under normobaric conditions normal atmospheric pressure
Detailed Description:
None
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?:
None