Brain Injuries Clinical Trial
Official title:
The Incidence and Magnitude of Cerebral Desaturation in Traumatic Brain Injury (TBI) Patients
We will determine the incidence and magnitude of cerebral desaturation in TBI. Adult patients (18 years and older) admitted to the Surgical/Trauma Intensive Care Unit (ICU) at the Health Sciences Center with a severe TBI will have cerebral oximetry monitoring instituted within 12 hours of admission and continuing for 72 hours after placement. Decreases in regional cerebral oxygenation will be correlated with ICU hemodynamic parameters including mean arterial pressure, intracranial pressure, and arterial oxygen and carbon dioxide tension.
In patients who have suffered a traumatic brain injury, the current management strategies
focus on the maintenance of normotension and normoxia and a normalized intracranial pressure
(ICP). Recent evidence calls into question the utility of ICP monitoring in these patients.
More advanced cerebral monitoring such as the use of invasive brain tissue oxygen monitors
have not found their way into widespread clinical practice. Cerebral oximetry monitoring
utilizes the different absorption characteristics of oxygenated and deoxygenated blood to
measure global brain oxygen levels.
While clinicians have no ability to reverse the primary brain injury, they can mitigate the
secondary injury effects, namely hypoxia and hypotension. It is well known that maintaining
normal blood pressure and oxygen saturation can prevent secondary brain injury. However, it
is also known that despite the appearance of normal hemodynamics, brain oxygen delivery in
the ischemic penumbra may be inadequate. This secondary brain injury is likely related to
decreases in cerebral oxygenation (rSO2).
There have been a number of studies that have examined a link between intraoperative
decreases in rSO2 and adverse perioperative outcome. These studies suggest that decreases in
rSO2 may be related to both adverse neurologic and non-neurologic sequelae. All of these
studies suffer from similar flaws, however. They are typically small in size, have varying
definitions of what constitutes a cerebral desaturation event, and have incompletely, or
poorly defined complications. Also lacking is a mechanistic explanation for the cerebral
desaturations as peripheral oxygen saturation typically remains near normal.
The brain can be considered the organ of highest priority when it comes to tissue
hypoperfusion during shock states. When oxygen delivery to the brain is decreased below a
critical value, cerebral desaturations occur. In the context of TBI, cerebral desaturation
may be the hallmark of secondary injury. Consistent with this hypothesis, in the largest
cerebral oximetry trial to date, Murkin and colleagues discovered that the incidence and
magnitude of cerebral desaturations was related to major non-neurologic organ morbidity.
Two questions arise in relation to this prior research. First, are these cerebral
desaturations causative of the adverse outcomes, and second if these desaturations were
treated (i.e. if cerebral oxygenation was normalized) would outcome be improved (i.e. or are
cerebral desaturations merely an epiphenomenon)?
This study will determine the incidence and severity of cerebral desaturation in traumatic
brain injury patients admitted to the Surgical Intensive Care Unit. We will examine factors
associated with cerebral desaturation such as ICP and blood pressure, and will determine if
decreases in rSO2 are helpful in prognostication of traumatic brain injury.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05542108 -
Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
|
N/A | |
Completed |
NCT03400904 -
Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome.
|
||
Completed |
NCT06073145 -
Transcranial Doppler Using Wearable Ultrasound Patch
|
||
Recruiting |
NCT03899532 -
Remote Ischemic Conditioning in Traumatic Brain Injury
|
N/A | |
Recruiting |
NCT06010823 -
Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants
|
N/A | |
Not yet recruiting |
NCT05833568 -
Five-day 20-minute 10-Hz tACS in Patients With a Disorder of Consciousness
|
N/A | |
Withdrawn |
NCT04288076 -
The Brain and Lung Interaction (BALI) Study
|
N/A | |
Completed |
NCT03162484 -
Physical Activity and Chronic Acquired Brain Injury
|
N/A | |
Not yet recruiting |
NCT02756585 -
Computed Tomography Perfusion in Patients With Severe Head Injury
|
N/A | |
Terminated |
NCT01430988 -
Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury
|
N/A | |
Completed |
NCT01093053 -
Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations
|
N/A | |
Completed |
NCT00975338 -
The LETS Study: A Longitudinal Evaluation of Transition Services
|
||
Completed |
NCT00878631 -
Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline
|
Phase 2/Phase 3 | |
Completed |
NCT03166722 -
Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition
|
N/A | |
Not yet recruiting |
NCT04478812 -
Tbit System Precision and Correlation of Different Blood Samples
|
N/A | |
Recruiting |
NCT05309005 -
Virtual Reality and Social Cognition After Acquired Brain Injury
|
||
Recruiting |
NCT05443542 -
VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI
|
N/A | |
Completed |
NCT02702635 -
Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging
|
N/A | |
Withdrawn |
NCT04247321 -
Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure
|
N/A | |
Not yet recruiting |
NCT04386525 -
Omega 3 and Ischemic Stroke; Fish Oil as an Option
|
Phase 4 |