Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170352
Status:
COMPLETED
Last Update Posted:
2015-08-28
First Post:
2005-09-12
Brief Title:
Comparison Between Different Types of Oxygen Treatment Following Traumatic Brain Injury
Sponsor:
Hennepin Healthcare Research Institute
Organization:
Hennepin Healthcare Research Institute
Study Overview
Official Title:
Hyperbaric and Normobaric Oxygen in Severe Brain Injury
Status:
COMPLETED
Status Verified Date:
2015-08
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 purpose of this study is to study the effects of EARLY no more than 24 four hours from injury administration of extra amounts of oxygen on traumatic brain injury
Detailed Description:
Brain injury continues to be a major cause of death and disability throughout the world Our investigations of hyperbaric oxygen treatment HBOT indicate that it is a relatively safe treatment that has promise as a potential therapy for patients with severe traumatic brain injury TBI The goals of the present proposal are to further elucidate the mechanisms of action of HBOT on severe TBI and to test hypotheses that are crucial to the possible future design of a Phase III clinical trial
Our initial prospective clinical trial to assess the effectiveness of HBOT in severe TBI documented very significant improvement in survival particularly in certain subgroups of patients In our second study HBOT was found to improve cerebral aerobic metabolism in patients with severe TBI reduce elevated intracranial pressure and had a persistent positive effect for at least six hours following the treatment Our work suggests that HBOT allows the brain to utilize increased amounts of oxygen more efficiently following treatment
Recently increasing the inspired oxygen concentration FiO2 to 100 has been proposed as an alternative way of delivering supranormal levels of oxygen to severe TBI patients Experimental investigation in the fluid percussion rat model using HBOT at 15 ATA atmospheres absolute for 60 minutes followed by 3 hours of 100fraction of inspired oxygen FiO2 have given optimum results in terms of mitochondrial functional and neurobehavioral improvement
The clinical and experimental data together provide a strong basis for the restorative effect of the combination of hyper- and normobaric hyperoxia on severe TBI The goal of this study is to evaluate the use of HBOT and 100 FiO2 separately and in combination
Our initial prospective clinical trial to assess the effectiveness of HBOT in severe TBI documented very significant improvement in survival particularly in certain subgroups of patients In our second study HBOT was found to improve cerebral aerobic metabolism in patients with severe TBI reduce elevated intracranial pressure and had a persistent positive effect for at least six hours following the treatment Our work suggests that HBOT allows the brain to utilize increased amounts of oxygen more efficiently following treatment
Recently increasing the inspired oxygen concentration FiO2 to 100 has been proposed as an alternative way of delivering supranormal levels of oxygen to severe TBI patients Experimental investigation in the fluid percussion rat model using HBOT at 15 ATA atmospheres absolute for 60 minutes followed by 3 hours of 100fraction of inspired oxygen FiO2 have given optimum results in terms of mitochondrial functional and neurobehavioral improvement
The clinical and experimental data together provide a strong basis for the restorative effect of the combination of hyper- and normobaric hyperoxia on severe TBI The goal of this study is to evaluate the use of HBOT and 100 FiO2 separately and in combination
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH-5 RO1 NS042126-03 | None | None | None |