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Also known as Hyperbaric oxygen (1.5 ATA, no NBH)
Hyperbaric oxygen · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Hyperbaric oxygen (1.5 ATA, no NBH) | EXPERIMENTAL | Hyperbaric oxygen at 1.5 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days. |
| Hyperbaric oxygen (2.0 ATA, no NBH) | EXPERIMENTAL | Hyperbaric oxygen at 2.0 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days. |
| Hyperbaric oxygen (2.5 ATA, no NBH) | EXPERIMENTAL | Hyperbaric oxygen at 2.5 ATA for 1 hour, without NBH. This treatment is administered twice a day for 5 days. |
| Hyperbaric oxygen (1.5 ATA + NBH) | EXPERIMENTAL | Hyperbaric oxygen at 1.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days. |
| Hyperbaric oxygen (2.0 ATA + NBH) | EXPERIMENTAL | Hyperbaric oxygen at 2.0 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days. |
| Hyperbaric oxygen (2.5 ATA + NBH) | EXPERIMENTAL | Hyperbaric oxygen at 2.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days. |
| Normobaric Hyperoxia (NBH) | EXPERIMENTAL | Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days. |
| Usual care | ACTIVE_COMPARATOR | Usual care for severe TBI |
| Name | Type | Description |
|---|---|---|
| Hyperbaric oxygen (1.5 ATA, no NBH) | DRUG | HBO at 1.5 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead |
| Hyperbaric oxygen (2.0 ATA, no NBH) | DRUG | HBO at 2.0 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead |
| Hyperbaric oxygen (2.5 ATA, no NBH) | DRUG | HBO at 2.5 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead |
| Hyperbaric oxygen (1.5 ATA + NBH) | DRUG | HBO at 1.5 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead |
| Hyperbaric oxygen (2.0 ATA + NBH) | DRUG | HBO at 2.0 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead |
| Hyperbaric oxygen (2.5 ATA + NBH) | DRUG | HBO at 2.5 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead |
| Normobaric Hyperoxia (NBH) | DRUG | 100% fraction of inspired oxygen (FiO2) for 4.5 hours twice a day for five days or until patient following commands or brain dead |
| Usual Care | OTHER | Will be treated with usual and customary care for severe traumatic brain injury |
Inclusion Criteria: * Age 16 years or older and 65 years or younger * Present with severe TBI, defined as Glasgow Coma Scale (GCS) of 3 to 8. * Marshall computerized tomography (CT) score \>1 in patients with a GCS of 7 or 8 or patients with an alcohol level \>200 mg/dl * Ability to initiate the fi...
Hyperbaric oxygen is being studied as a treatment for Traumatic Brain Injury. It is currently in Phase 2 clinical development as an investigational therapy. The treatment involves administering oxygen at increased atmospheric pressure, and it is being evaluated for its potential to improve outcomes in patients with this condition.
Hyperbaric oxygen does not target a specific molecular receptor or pathway. Instead, it works by delivering increased oxygen levels to tissues under elevated atmospheric pressure, which may help reduce brain injury and promote recovery after trauma. This mechanism is being investigated in the context of Traumatic Brain Injury.
Hyperbaric oxygen is being developed by National Healthcare Corp., a company traded under the ticker symbol NHC. The company is conducting clinical research to evaluate the therapy's safety and efficacy for Traumatic Brain Injury.
Hyperbaric oxygen is currently in Phase 2 clinical trials. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 study is designed to assess its effects in patients with Traumatic Brain Injury.
Hyperbaric oxygen is being evaluated in one active Phase 2 clinical trial, identified as NCT02407028, titled 'Hyperbaric Oxygen Brain Injury Treatment Trial.' This randomized, active-controlled study is recruiting 200 participants with Traumatic Brain Injury at sites in the United States and Canada.
Yes, Hyperbaric oxygen is also known as Hyperbaric oxygen (1.5 ATA, no NBH). The alternative name specifies the treatment protocol, which involves administering oxygen at 1.5 atmospheres absolute without the use of normobaric hyperoxia. Both names refer to the same investigational therapy.