Feasibility of Using NeuraSignal Transcranial Doppler Robot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NeuraSignal transcranial doppler robot.
- Who it may be relevant to
- Registry conditions: Cerebral Autoregulation. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device NeuraSignal transcranial doppler robot
measure cerebral blood flow correlated with arterial blood pressure to generate individualized cerebral autoregulatory curves
Primary outcome measures
- Primary outcome [Time frame: one year]
Secondary outcome measures (1)
- Secondary outcome [Time frame: one year]
Eligibility criteria
Inclusion criteria
- 18-89
- Patients admitted to the Neuro ICU for blood pressure management (MAP management) after spinal surgery
Exclusion criteria
- Patients under 18 years (or bodyweight <50kg if age unknown),
- prisoners
- pregnant women,
- non-English speaking,
- patients enrolled in concurrent
- ongoing interventional trial
- students of UAB
- employees of UAB
- targeting specific populations
- patients with previously diagnosed brain pathology
- patients with open wounds over temporal bones precluding transcranial doppler
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- UAB Department of Anesthesiology and Perioperative Medicine — Birmingham
Identifiers
NCT: NCT06565442 · IRB-300013270 · UAB