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

NCT05387018 | Completed

• 1 other identifier: 2022-0031
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; hyperbaric oxygen; non-acute

Outcome Measures

Primary Outcomes (2)

• 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

  2014-2024

• Glasgow Outcome Scale-Extend

  The GOSE measures overall disability (independence, work, social and leisure activities, family and friendship and return to normal life) after TBI and divides patients into the following outcome categories: 1= dead; 2 = vegetative state (VS); 3 = lower severe disability and complete dependence on others (Lower SD); 4 = upper severe disability and some dependency on others, but can be alone (on their own ) for 8 hours (Upper SD); 5= lower moderate disability, living independently, (not working or) working at a lower level of performance/sheltered work (Lower MD); 6 = upper moderate disability and returning to previous work with adjustments (Upper MD); 7 = lower good recovery with (almost back at full functional recovery) only minor physical or mental deficits (minor disability) (Lower GR);8 = upper good recoverythat implies full functional recovery (without any disability) (Upper GR)

  2014-2024

Secondary Outcomes (2)

• Glasgow Outcome Scale, GOS

  2014-2024

• Functional Independence Measure （FIM）

  2014-2024

Study Arms (2)

Observation group (hyperbaric oxygen + routine rehabilitation treatment)

no special intervention

control group (routine rehabilitation treatment)

no special intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had been hospitalized for rehabilitation in our rehabilitation unit after traumatic brain injury, to study the differences in outcomes between those who received hyperbaric oxygen therapy within 3 months of injury and those who did not

You may qualify if:

• The age ranges from 18 to 90
• Traumatic brain injury, 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

You may not qualify if:

• Penetrating head injury
• Combined with spinal cord injury or peripheral nerve injury
• Severe coagulopathy
• Severe heart function, liver function, kidney function and other organ function abnormality
• The investigator considers the subject to be at potential risk or to have any other factors that may interfere with the subject

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

• Zhang Z, Li Z, Li S, Xiong B, Zhou Y, Shi C. Hyperbaric oxygen for moderate-to-severe traumatic brain injury: outcomes 5-8 years after injury. Med Gas Res. 2025 Mar 1;15(1):156-163. doi: 10.4103/mgr.MEDGASRES-D-24-00018. Epub 2024 Sep 25.

  PMID: 39324933 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Bing Xiong, master

  director of department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: May 24, 2022
• Study Start: March 31, 2022
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: February 10, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)