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Prolonged Automated Robotic TCD Monitoring in Acute Severe TBI: Study Design and Rationale

  • Big Data in Neurocritical Care
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Abstract

Background

Transcranial Doppler ultrasonography (TCD) is a portable, bedside, noninvasive diagnostic tool used for the real-time assessment of cerebral hemodynamics. Despite the evident utility of TCD and the ability of this technique to function as a stethoscope to the brain, its use has been limited to specialized centers because of the dearth of technical and clinical expertise required to acquire and interpret the cerebrovascular parameters. Additionally, the conventional pragmatic episodic TCD monitoring protocols lack dynamic real-time feedback to guide time-critical clinical interventions. Fortunately, with the recent advent of automated robotic TCD technology in conjunction with the automated software for TCD data processing, we now have the technology to automatically acquire TCD data and obtain clinically relevant information in real-time. By obviating the need for highly trained clinical personnel, this technology shows great promise toward a future of widespread noninvasive monitoring to guide clinical care in patients with acute brain injury.

Methods

Here, we describe a proposal for a prospective observational multicenter clinical trial to evaluate the safety and feasibility of prolonged automated robotic TCD monitoring in patients with severe acute traumatic brain injury (TBI). We will enroll patients with severe non-penetrating TBI with concomitant invasive multimodal monitoring including, intracranial pressure, brain tissue oxygenation, and brain temperature monitoring as part of standard of care in centers with varying degrees of TCD availability and experience. Additionally, we propose to evaluate the correlation of pertinent TCD-based cerebral autoregulation indices such as the critical closing pressure, and the pressure reactivity index with the brain tissue oxygenation values obtained invasively.

Conclusions

The overarching goal of this study is to establish safety and feasibility of prolonged automated TCD monitoring for patients with TBI in the intensive care unit and identify clinically meaningful and pragmatic noninvasive targets for future interventions.

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Acknowledgements

We would like to sincerely thank the Curing Coma Campaign Scientific Advisory Council for providing insights and feedback related to the project as well as Karen G. Hirsch and Jonathan Elmer for their insight and guidance on the research protocol.

Funding

The work reported in this publication was partially supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Numbers U24NS100659 and U24NS100655. The content is solely the responsibility of the authors and does not represent the official views of the National Institutes of Health.

Author information

Authors and Affiliations

  1. Department of Neurology, Virginial Commonwealth University, Richmond, VA, USA

    Shraddha Mainali

  2. Department of Neurology, University of Texas Southwestern Medical Center, Dallas, TX, USA

    Danilo Cardim

  3. Department of Neurology, Wake Forest School of Medicine, Winston Salem, NC, USA

    Aarti Sarwal

  4. Departments of Emergency Medicine and Neurology, University of Florida College of Medicine, Gainesville, FL, USA

    Lisa H. Merck

  5. Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA

    Sharon D. Yeatts

  6. Brain Physics Laboratory, Neurosurgical Unit, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK

    Marek Czosnyka

  7. Department of Critical Care Medicine, Neurology, and Neurosurgery, University of Pittsburgh, Pittsburgh, PA, USA

    Lori Shutter

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Contributions

SM: conceptualized and designed the research protocol and drafted and finalized the article. DC: conceptualized and designed the research protocol and drafted and finalized the article. AS: conceptualized and designed the research protocol and drafted and finalized the article. LM: significant contribution to the design and concept of the protocol and provided critical input and edits on the article. SY: significant contribution to the design and concept of the protocol and provided critical input and edits on the article. MC: significant contribution to the design and concept of the protocol and provided critical input and edits on the article. LS: significant contribution to the design and concept of the protocol and provided critical input and edits on the article. The authors approved of the final manuscript.

Corresponding author

Correspondence to Shraddha Mainali.

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Conflicts of interest

SY: National Institute of Neurological disorders (NINDS) grant funds to institution related to Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) Data Coordinating Center (DCC), Brain Oxygen Optimization in Severe TBI - Phase 3 (BOOST-3) study. MC: Receives licensing fee for ICM+ (Intensive Care Monitoring) software. The remaining authors have no conflicts to disclose.

Ethical approval/informed consent

This is a design and rationale article of an upcoming trial that will be conducted after appropriate ethical approval from participating sites. Informed consent will be used to enroll participants in this observational study.

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Mainali, S., Cardim, D., Sarwal, A. et al. Prolonged Automated Robotic TCD Monitoring in Acute Severe TBI: Study Design and Rationale. Neurocrit Care 37 (Suppl 2), 267–275 (2022). https://doi.org/10.1007/s12028-022-01483-6

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