Ignite Creation Date:
2024-05-06 @ 12:35 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01605838
Status:
WITHDRAWN
Last Update Posted:
2015-01-14
First Post:
2012-05-22
Brief Title:
Noninvasive Monitoring of Cerebral Blood Flow Autoregulation in Patients With Traumatic Brain Injury TBI
Sponsor:
Advanced Brain Monitoring Inc
Organization:
Advanced Brain Monitoring Inc
Study Overview
Official Title:
Pilot Feasibility Study of New Portable Monitor for Continuous Assessment of Cerebral Blood Flow CBF Autoregulation in Patients With Moderate to Severe Traumatic Brain Injury TBI
Status:
WITHDRAWN
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
A series of administrative delays on all sides involved combined with funding problems
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REG01
Brief Summary:
BACKGROUND The brain is very sensitive to both excessive and insufficient flow of blood Cerebral blood flow CBF is normally auto-regulated by the blood vessels in the brain but this protective mechanism is often disturbed after a traumatic brain injury TBI Impairment or loss of the CBF autoregulation makes the brain vulnerable to oscillations of either arterial blood pressure ABP or intracranial pressure ICP The ideal management of TBI patients therefore involves continuous measurement and management of the cerebral perfusion pressure CPP ABP - ICP but the measurement of CPP is currently possible only with specialized equipment and expertise that is not available in all institutions The investigators have converted a no-longer used system that continuously monitors CBF autoregulation using rheoencephalography REG technology into a modern small battery-powered low-cost monitor aka BM-1 that acquires the REG signals using only noninvasive electrodes placed on the skinscalp REG data can then be used to calculate the optimal CPP to maintain in each individual patient BM-1 is also capable of monitoring electroencephalography EEG and impedance plethysmography IPG which can respectively be used to measure brain electrical activity and changes in peripheral blood flow caused by blood pressure changes
OBJECTIVES The primary objectives are to Obj 1 demonstrate that REG acquired noninvasively is equal to the well-established but invasive method using intracranial pressure ICP monitoring Obj 2 retrospectively test the idea that TBI patients have a less favorable outcome if their CPP were found less optimal using the REG data and Obj 3 determine if noninvasive IPG or the PPG finger sensor monitoring used to measure heart rate in doctors offices can replace the invasive monitoring of arterial blood pressure ABP
METHODOLOGY This is an observational study with retrospective data analysis 20 adult patients 18-65 yrs with acute TBI who meet the inclusionexclusion criteria will be enrolled on a first-come-first-enroll basis The enrolled patients will have the REG EEG and IPG signals monitored for the duration of ICU stay or 15 days whichever is shorter Standard neurological assessment will be made at the patients discharge from the ICU and at 3 months after injury The study is expected to end June 2013
OBJECTIVES The primary objectives are to Obj 1 demonstrate that REG acquired noninvasively is equal to the well-established but invasive method using intracranial pressure ICP monitoring Obj 2 retrospectively test the idea that TBI patients have a less favorable outcome if their CPP were found less optimal using the REG data and Obj 3 determine if noninvasive IPG or the PPG finger sensor monitoring used to measure heart rate in doctors offices can replace the invasive monitoring of arterial blood pressure ABP
METHODOLOGY This is an observational study with retrospective data analysis 20 adult patients 18-65 yrs with acute TBI who meet the inclusionexclusion criteria will be enrolled on a first-come-first-enroll basis The enrolled patients will have the REG EEG and IPG signals monitored for the duration of ICU stay or 15 days whichever is shorter Standard neurological assessment will be made at the patients discharge from the ICU and at 3 months after injury The study is expected to end June 2013
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W81XWH - 10 - C - 0061 | OTHER_GRANT | DOD TATRC | None |