Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565442
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Feasibility of Using NeuraSignal Transcranial Doppler Robot
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of Using NeuraSignal Transcranial Doppler Robot for Generating Cerebral Autoregulation Curves in Neuro ICU Patients Admitted for Blood Pressure Management After Spinal Surgery
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:
None
Brief Summary:
The purpose of this study is to determine the feasibility of using the NeuraSignal transcranial doppler robot in a neuro ICU setting to measure cerebral blood flow correlated with arterial blood pressure to generate individualized cerebral autoregulatory curves
Detailed Description:
This study aims to explore the feasibility of using the NeuraSignal transcranial doppler robot to generate cerebral autoregulation curves in adult patients admitted to the neuro ICU with a newly diagnosed brain mass Cerebral blood flow measurements as calculated by a transcranial doppler robot will be time-correlated with arterial blood pressure measurements to generate personalized cerebral autoregulation curves The study will be conducted prospectively and observationally on 20 patients as a pilot study for feasibility management
Cerebral autoregulation has historically been difficult to quantify in part due to the difficulty in measuring cerebral blood flow directly Transcranial doppler TCD is a well-established method of calculating cerebral blood flow based on velocity through the middle cerebral arteries however traditional methods of performing TCD are time consuming and require technical and procedural training It also carries the established risk of miscalculation with variation in intra-operator technique differences and miscalculations due to inappropriate angle of the probe The NeuraSignal transcranial doppler robot offers a potential tool to make obtaining cerebral blood flow calculations easier and with the use of AI to determine optimal windows significantly decreases intra-operator differences and errors associated with inappropriate probe angle Cerebral blood flow calculated in this way can then be correlated with arterial blood pressure and used to build cerebral autoregulatory curves in near real time This study aims to build on previous studies deriving and using personalized cerebral autoregulatory curves and determine the feasibility of using the TCD robot in this way to make individualized cerebral autoregulatory curves more accessible as a tool for personalized blood pressure management
Cerebral autoregulation has historically been difficult to quantify in part due to the difficulty in measuring cerebral blood flow directly Transcranial doppler TCD is a well-established method of calculating cerebral blood flow based on velocity through the middle cerebral arteries however traditional methods of performing TCD are time consuming and require technical and procedural training It also carries the established risk of miscalculation with variation in intra-operator technique differences and miscalculations due to inappropriate angle of the probe The NeuraSignal transcranial doppler robot offers a potential tool to make obtaining cerebral blood flow calculations easier and with the use of AI to determine optimal windows significantly decreases intra-operator differences and errors associated with inappropriate probe angle Cerebral blood flow calculated in this way can then be correlated with arterial blood pressure and used to build cerebral autoregulatory curves in near real time This study aims to build on previous studies deriving and using personalized cerebral autoregulatory curves and determine the feasibility of using the TCD robot in this way to make individualized cerebral autoregulatory curves more accessible as a tool for personalized blood pressure management
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