|Age:||14 and older|
|Keywords:||Traumatic Brain Injury, TBI, Severe, Head, Trauma, Brain, Brain Oxygen|
• All participants will have both an ICP monitor and a PbtO2 oxygen monitor placed.
• Participants will have an equal chance (like the flip of a coin) of being allocated to one of the two groups. The groups determine which information about the brain will be used to guide medical care.
o Group 1: medical care guided by ICP monitoring (the PbtO2 monitor is covered and not used)
o Group 2: medical care guided by ICP and PbtO2 monitoring
• This random (like the flip of a coin) allocation to one group or another is research.
• Medical care of the participant will be guided by this group allocation (which group the participant is in) for 5 days.Information is collected for the study from participants’ medical record, diagnostic images, and monitors. Information collected includes the condition of the patient and the treatments being provided.
• We will call participants (or their caregivers) about 5 times after their injury. We will call about once each month for 5 months. Each phone call will last about 15 minutes. During the phone call, we will ask how they are doing, if they are having any additional problems, and if any of their contact information has changed.
• We will ask the participant to come in for a study visit about 6 months after their brain injury. If they are not well enough to travel, a member of the study team can visit them where they are living, if they agree. The visit will take about 1 hour. During the visit, a study team member will ask questions about the participant’s recovery. There will be a questionnaire and some pencil and paper exercises.
● People who are 14 years or older, with a
● Blunt closed head injury, with
● Severe brain injury, and
● Can start the study immediately following brain monitor placement.
People who meet the entry criteria will be randomly entered, like flipping a coin, into one of the two study groups:
● Those that get medical care based on monitoring of pressure in the brain (intracranial pressure or ICP) alone.
● Those who get medical care based on both ICP and the amount of oxygen in the brain (brain tissue oxygen or PbtO2).
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.