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

NCT ID: NCT06816199

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2030-12-31

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.

Conditions

Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-hyperbaric oxygen exposure group

Participants with traumatic brain injuries will always be excluded from hyperbaric oxygen therapy

Hyperbaric oxygen exposure

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: collaborator

Fu Xing Hospital, Capital Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhihua Zhang

Role: PRINCIPAL_INVESTIGATOR

Departments of Physical Medithe Second Affiliated Hospital of Zhejiang University School of Medicine

Sujuan Li

Role: STUDY_DIRECTOR

Fu Xing Hospital, Capital Medical University

Locations

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhihua Zhang

Role: CONTACT

2511097@zju.edu.cn

+8613757159433

Shuyang Li

Role: CONTACT

2323035@zju.edu.cn

+8615167169440

Facility Contacts

Zhihua Zhang, master

Role: primary

2511097@zju.edu.cn

+86 13757159433

References

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Reference Type: BACKGROUND

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Other Identifiers

2024-1224

Identifier Type: -

Identifier Source: org_study_id