Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504238
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIMABI
Brief Summary:
Life-threatening mass effect LTME arises when brain swelling displaces or compresses crucial midline structures subsequent to acute brain injuries ABIs like traumatic brain injury TBI ischemic stroke IS and intraparenchymal hemorrhage IPH which can manifest rapidly within hours or more gradually over days Despite advancements in surgical management significant gaps in understanding persist regarding optimal monitoring and therapeutic approaches The current standard for identifying LTME involves neurologic decline in conjunction with radiographic evidence or increased intracranial pressure ICP indicating space-occupying mass effect However in critically ill patients reliance on subjective physical exam findings such as decreased arousal often leads to delayed recognition occurring only after catastrophic shifts have already occurred
The goal of this study is to determine the association of non-invasive biomarkers with neurologic deterioration and to determine whether non-invasive biomarker inclusion improves detection of outcome and decline
The investigators propose to use various non-invasive methods to monitor ICP as adjuncts in detecting deteriorating mass effect These methods include quantitative pupillometry radiographic data laboratory data and other bedside diagnostic tests available including electroencephalography EEG skull vibrations detected via brain4care device optic nerve sheath diameter assessment ONSD and ultrasound-guided eyeball compression Some of these methods will be measured only for the purposes of the research study such as skull vibrations via brain4care Other measurements such as quantitative pupillometry will represent additional measurements beyond those already being collected for clinical care This research study is necessary to understand the association of these non-invasive biomarkers with neurological decline and outcomes while considering potential confounding factors
The goal of this study is to determine the association of non-invasive biomarkers with neurologic deterioration and to determine whether non-invasive biomarker inclusion improves detection of outcome and decline
The investigators propose to use various non-invasive methods to monitor ICP as adjuncts in detecting deteriorating mass effect These methods include quantitative pupillometry radiographic data laboratory data and other bedside diagnostic tests available including electroencephalography EEG skull vibrations detected via brain4care device optic nerve sheath diameter assessment ONSD and ultrasound-guided eyeball compression Some of these methods will be measured only for the purposes of the research study such as skull vibrations via brain4care Other measurements such as quantitative pupillometry will represent additional measurements beyond those already being collected for clinical care This research study is necessary to understand the association of these non-invasive biomarkers with neurological decline and outcomes while considering potential confounding factors
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None