the Effects of Hyperbaric Oxygen on Non-acute Traumatic Brain Injury

Study Overview
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Brief Summary
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Traumatic brain injury (TBI) continues to be a major cause of death and disability throughout the world. The reduced cerebral blood flow secondary to the direct trauma-induced damage deregulates cerebral metabolism and depletes energy stores within the brain. Diffusion barriers to the cellular delivery of oxygen develop and persist. Besides, TBI often leads to intracranial hypertension, which in turn exacerbates diffusion disorders, further reducing cerebral oxygenation, and deteriorates the injury. By increasing the partial pressure of oxygen in blood, reducing intracranial pressure and cerebral edema, Hyperbaric oxygen therapy (HBO2) has been used in early treatment of TBI. However, due to the different severity of TBI, the clinical situation of early insult is complex and unpredictable, ordinarily there was a time delay between TBI and onset of HBO2 treatment averaging more than 2 weeks, especially in patients with severe TBI. Whether the delayed intervention is still effective is controversial.

Detailed Description
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Traumatic brain injury (TBI) continues to be a major cause of death and disability throughout the world. The pathophysiological processes which occur post-TBI are complex and have not been fully elucidated. Penetrating injury, mechanical stress, cceleration-deceleration injury, and shear forces provide the direct trauma-induced damage. Subsequently, the reduced cerebral blood flow deregulates cerebral metabolism and depletes energy stores within the brain. Diffusion barriers to the cellular delivery of oxygen develop and persist. Besides, TBI often leads to intracranial hypertension, which in turn exacerbates diffusion disorders, further reducing cerebral oxygenation, and deteriorates the injury. Ischemia has been implicated as a major cause of secondary brain injury and death following severe brain injury. Hyperbaric oxygen therapy (HBO2) has been used in early treatment of TBI. Studies have shown that increased tissue oxygen delivery is capable of driving an increase in oxygen utilization, leading to improved cerebral aerobic metabolism. By increasing the partial pressure of oxygen in blood, HBO2 increases cerebral oxygen saturation. In addition, HBO2 has been shown in both experimental and clinical studies to reduce intracranial pressure and cerebral edema after severe TBI. HBO2 has been shown to decrease mortality rates and improve functional outcome in severely brain-injured patients. However, due to the different severity of TBI, the clinical situation of early insult is complex and diverse, and a considerable number of patients in the acute stage was accompanied by unstable intracranial hemorrhage, hemodynamic instability, ventilator assisted ventilation and other unpredictable conditions, therefore, ordinarily there was a time delay between TBI and onset of HBO2 treatment averaging more than 2 weeks, especially in patients with severe TBI. Whether the delayed intervention is still effective is controversial.

Official Title
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the Effects of Hyperbaric Oxygen on Moderate and Severe Non-acute Traumatic Brain Injury

Conditions
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Traumatic Brain Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age ranges from 18 to 60 Moderate to severe traumatic brain injury, conforming to one of the following indicators: Loss of consciousness ≥30 minutes within 24 hours after trauma Anterograde amnesia ≥24 hours after trauma Glasgow coma scale score < 13 (excluding all poisoning, sedation and shock factors) Head CT scan confirmed the presence of at least one of the following findings: Intracranial hemorrhage, subdural hematoma, epidural hematoma, brain contusion, hemorrhagic brain contusion, subarachnoid hemorrhage, brain stem injury Those who had good compliance, signed informed consent and were eligible for inclusion according to the investigator's judgment. Exclusion Criteria: Penetrating head injury Combined with spinal cord injury or peripheral nerve injury History of severe lung disease, such as asthma, chronic obstructive pulmonary disease Severe coagulopathy Severe heart function, liver function, kidney function and other organ function abnormality Previous history of brain diseases such as brain trauma, stroke, brain tumor and intracranial infection Prior to injury, there was a history of cognitive or psychiatric abnormalities The investigator considers the subject to be at potential risk or to have any other factors that may interfere with the subject

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation group (hyperbaric oxygen + routine rehabilitation treatment)<br> | |
| control group (routine rehabilitation treatment)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Scale, GOS | The Glasgow Outcome Scale was divided into five scales, with poor prognosis at scales 1 to 3 and good prognosis at scales 4 to 5 | 2014-2021 | 
| Disability Rating Scale, DRS | Different points of DRS represent the degree of disability: 0 point : No; 1 point: Mild; 2-3 points: Partial; 4-6 points: Obvious; 7-11 points: Moderately severe; 12 to 16 points: Severe; 17-21 points: Extremely severe; 22-24: Vegetative state; 25-29 points: Extreme vegetative state; 30: Death | 2014-2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury, hyperbaric oxygen, non-acute