RECRUITINGOBSERVATIONAL

The Safety and the Efficiency of Hyperbaric Oxygen in Traumatic Brain Injury

A Prospective Cohort Study Exploring the Safety and the Efficiency of Hyperbaric Oxygen in Treating Traumatic Brain Injury During Nonacute Phrase

About This Trial

The goal of this observational study is to learn about the safety and long-term effects of hyperbaric oxygen therapy in participants over the age of 18 with traumatic brain injury (TBI). The main question it aims to answer are: Does hyperbaric oxygen therapy raise independence in daily living and the ability to engage in social activities in participants with TBI when treated with hyperbaric oxygen therapy during the non-acute phrase after injury? What medical problems do participants have when treated with hyperbaric oxygen therapy? Whether or not participants have used hyperbaric oxygen therapy as part of their routine medical treatment for TBI, they will answer online or telephone survey questions about their functional independence for 2 years.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 18\~90 years old 2. Patients with traumatic brain injury admitted to the rehabilitation department meet one of the following indicators: 1\) Clear history of exogenous trauma-causing disease (such as car accidents, heavy objects, falls, violent assaults, explosive injuries, etc.) 2) GCS score of 3 to 15 points (excluding all kinds of poisoning, sedation, shock factors) 3. Clear presence of at least one of the following imaging signs on cranial CT or MRI: Traumatic intracranial hemorrhage, subdural hematoma, epidural hematoma, cerebral contusion, ventricular hemorrhage, subarachnoid hemorrhage, or brainstem injury; 4. good compliance, signed willing to sign a consent form, and those who were judged by the investigator to be eligible for enrollment. Who Should NOT Join This Trial: 1. Sequelae of previous spinal cord injury or combination of spinal cord injury in this injury; 2. Severe coagulation disorders; 3. Pregnancy status; 4. Any other factors that the investigator considers to be a potential risk to the subject or that interfere with the subject. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age 18\~90 years old 2. Patients with traumatic brain injury admitted to the rehabilitation department meet one of the following indicators: 1\) Clear history of exogenous trauma-causing disease (such as car accidents, heavy objects, falls, violent assaults, explosive injuries, etc.) 2) GCS score of 3 to 15 points (excluding all kinds of poisoning, sedation, shock factors) 3. Clear presence of at least one of the following imaging signs on cranial CT or MRI: Traumatic intracranial hemorrhage, subdural hematoma, epidural hematoma, cerebral contusion, ventricular hemorrhage, subarachnoid hemorrhage, or brainstem injury; 4. good compliance, signed informed consent, and those who were judged by the investigator to be eligible for enrollment. Exclusion Criteria: 1. Sequelae of previous spinal cord injury or combination of spinal cord injury in this injury; 2. Severe coagulation disorders; 3. Pregnancy status; 4. Any other factors that the investigator considers to be a potential risk to the subject or that interfere with the subject.

Treatments Being Tested

OTHER

Hyperbaric oxygen exposure

Between 1 week and 3 months after the traumatic brain injury, participants will receive hyperbaric oxygen therapy on a 2.0 ATA protocol for 60 minutes once a day, five times a week.

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China