Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423469
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
Noninvasive Intracranial Pressure Waveforms Assessment in Traumatic Brain Injury
Sponsor:
Sergio Brasil MD
Organization:
University of Sao Paulo
Study Overview
Official Title:
A Multicenter Observational Cohort for the Determination of Noninvasive Intracranial Pressure Waveforms Role in Traumatic Brain Injury
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In clinical practice hospital admission of patients with altered level of consciousness ranging from drowsiness to decreasing response states or coma is extremely common This clinical condition demands effective investigation and early treatment Imaging and laboratory tests have played increasingly relevant roles in supporting clinical research One of the main causes of coma is intracranial hypertension IH with traumatic brain injuries TBI and cerebral hemorrhages being the major contributors to its development IH increases the risk of secondary damage in these populations and consequently morbidity and mortality Clinical studies show that adequate intracranial pressure ICP control in TBI patients reduces mortality and increases functionality Unfortunately the most accurate way to measure and evaluate the ICP is through a catheter located inside the skull and its perforation is required for this purpose Several studies have attempted to identify noninvasive solutions for ICP monitoring however to date none of the techniques gathered sufficient evidence to replace invasive monitors Recently an extensometer device has been developed which only maintains contact with the skulls skin and therefore eliminates the need for its perforation being able to obtain recordings of cranial dilatation at each heartbeat and consequently reflecting brain compliance In vivo studies have identified excellent qualitative correlation with catheter ICP recordings However this device was evaluated only in a limited number of clinical cohorts and the correlations between the information provided by this device with patients outcomes is still poor Therefore this project aims primarily to evaluate the use of this noninvasive brain compliance monitoring system in a cohort of TBI patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None