Carbon Dioxide for Traumatic Brain Injury
(COPETBI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether inhaling specific amounts of carbon dioxide (CO2) can help the brain clear waste products more effectively. Researchers are studying individuals with a history of traumatic brain injury (TBI) and those without to observe how their brains respond to CO2. Participants will receive different doses of CO2 during separate visits. Suitable candidates include adults who have experienced a traumatic brain injury or are healthy without a history of severe head injuries or major health issues like severe asthma or heart problems. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on brain health.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. However, if you have a respiratory disease or a condition that might increase the risk of the study procedures, you may be excluded from participating.
What prior data suggests that carbon dioxide administration is safe for individuals with and without traumatic brain injury?
Research has shown that carbon dioxide (CO2) levels are important in patients with traumatic brain injury (TBI). Some studies have found that higher CO2 levels in the blood are linked to worse outcomes for these patients, highlighting the need to closely monitor CO2 levels.
This trial aims to determine if different CO2 levels can help the brain clear waste safely. Participants will receive varying amounts of CO2 to test this. The study is in the "Not Applicable" phase, indicating it isn't yet focused on human safety. However, since CO2 is naturally found in the body and used in controlled settings, it is generally safe in small, controlled amounts.
Considering possible risks is important, especially for people with TBI. Current research has not shown any serious or unexpected safety issues with the CO2 levels being tested in this study. Participants will be closely monitored to ensure their safety.12345Why are researchers excited about this trial?
Researchers are excited about using carbon dioxide administration for traumatic brain injury (TBI) because it explores a unique method of treatment. Unlike traditional approaches that focus on managing symptoms or preventing further injury, this technique aims to regulate blood flow in the brain directly by adjusting levels of carbon dioxide. This could potentially offer a more immediate and targeted way to help the brain recover after trauma, especially since current treatments mainly involve supportive care and medications that can take longer to show effects. By fine-tuning the carbon dioxide levels, researchers hope to optimize brain function and enhance recovery in individuals with TBI.
What evidence suggests that carbon dioxide administration could be effective for traumatic brain injury?
This trial will explore the effects of carbon dioxide (CO2) administration on individuals with traumatic brain injury (TBI) and healthy subjects. Research has shown that CO2 levels can affect recovery outcomes for TBI patients. Higher CO2 levels in the blood are linked to worse outcomes for TBI patients who need breathing support. Studies have also found a connection between the CO2 levels in a person's breath and the severity of their TBI. While the exact reasons are still under investigation, these findings suggest that managing CO2 levels might help remove waste from the brain more effectively, possibly leading to better recovery for TBI patients.13678
Who Is on the Research Team?
Andrew R Mayer, Phd
Principal Investigator
Mind Research Network
Are You a Good Fit for This Trial?
This trial is for adults aged 18-82, with or without a history of traumatic brain injury (TBI). Participants must be able to consent. For the TBI group, any severity level of adult-onset TBI is acceptable. Healthy individuals can also join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive different levels of CO2 to assess brain waste clearance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carbon Dioxide Administration
Trial Overview
The study examines if varying CO2 levels during an fMRI can enhance the brain's waste removal process. Each participant will experience different CO2 levels in a random order across visits, not knowing which dose they receive each time.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
A counter-balanced, cross-over design (AB/BA), in which individuals with TBI (aged 18-82 years) may be dosed to achieve 5 or 10 mmHG changes in ETCO2 across multiple visits.
A counter-balanced, cross-over design (AB/BA), in which individuals without a history of TBI (healthy subjects, aged 18-82 years) may be dosed to achieve 5 or 10 mmHG changes in ETCO2 across multiple visits.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Andrew Mayer
Lead Sponsor
Citations
PaCO2 Association with Traumatic Brain Injury Patients ...
Higher PaCO2 levels are associated with an unfavorable outcome in ventilated TBI patients. These results underscore the importance of PaCO2 level in TBI ...
End-tidal and arterial carbon dioxide gradient in serious ...
There is only moderate correlation of ETCO 2 and PaCO 2 at hospital arrival in patients with serious TBI. The mean ETCO 2 –PaCO 2 gradient was 1.7 (±1.0) kPa ( ...
Prehospital EtCO2 and mortality in suspected severe ...
Association between prehospital end‑tidal carbon dioxide levels and mortality in patients with suspected severe traumatic brain injury.
Effects of brain tissue oxygen (PbtO2) guided management ...
The primary outcome was survival with favourable neurological outcome at 6-months post injury. Data were extracted by two independent authors and GRADE ...
Arterial and End-Tidal Carbon Dioxide Levels in Children ...
Objective To examine the agreement between Paco2 and EtCO2 and associated factors in children with traumatic brain injury. Design, Setting, and ...
6.
hamilton-medical.com
hamilton-medical.com/en_US/Resource-center/Article-page~knowledge-base~a15e27d8-383a-4815-aaba-11702f644cb1~Prehospital-EtCO2-and-mortality-in-suspected-severe-traumatic-brain-injury-patients~.htmlPrehospital EtCO2 and mortality in suspected severe ...
Association between prehospital end-tidal carbon dioxide levels and mortality in patients with suspected severe traumatic brain injury.
Latent class growth analysis of dynamic PaCo2 patterns ...
This study identified distinct patterns of PaCO₂ dynamic changes in acute brain injury patients. Our analysis demonstrated that persistent ...
Agreement between arterial and end-tidal carbon dioxide in ...
The primary objective of this study was to describe the correlation and agreement between PaCO 2 and ETCO 2 in intubated adult trauma patients with TBI.
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