Traumatic Brain Injury
Conditions
Keywords
traumatic brain injury, hyperbaric oxygen
Brief summary
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.
Detailed description
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). This is a multicenter prospective cohort study. 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 during non-acute phrase after injury, they will answer online or telephone survey questions about their functional independence (including cognitive functioning, physical disability, mental status, employment and social activities) for 2 years.
Interventions
OTHERHyperbaric 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.
Sponsors
First People's Hospital of Hangzhou
Fu Xing Hospital, Capital Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extended Glasgow Outcome Scale,GOSE | 6-month, 12-month and 24-month after injury | Overall functional outcomes for participants with traumatic brain injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Function Independent Measure, FIM | 6-month, 12-month and 24-month after injury | This scale is for non-comatose patients after traumatic brain injury and includes motor and cognitive function ratings |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rivermead Post Concussion Symptoms Questionnaire，RPQ | 6-month, 12-month and 24-month after injury | Mainly for mild traumatic brain injury |
Countries
China
Contacts
Primary ContactZhihua Zhang
Backup ContactShuyang Li
Outcome results
None listed