Noninvasive Monitoring of Cerebral Blood Flow Autoregulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-18

Study Completion Date

2021-04-28

Brief Summary

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Rheoencephalography (REG) shows promise as a method for noninvasive neuromonitoring, because it reflects cerebrovascular reactivity. This protocol will study clinical and technical conditions required to use REG. Additionally, our goal is to study noninvasive peripheral bioimpedance pulse waveforms in order to substitute invasive SAP. A previous study demonstrated that REG can be used to detect spreading depolarization (SD), the early sign of brain metabolic disturbance. SD can be measured invasively with DC EEG amplifiers only. Our goal is to create an automatic notification function for REG monitoring indicating change of clinical conditions.

Detailed Description

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Neuromonitoring of patients with severe neurological illness are detailed elsewhere. In the setting of cerebral edema, ICP monitoring is a staple of neurocritical care. Pressure AR is an important hemodynamic mechanism that protects the brain against inappropriate fluctuations in CBF in the face of changing CPP. Both static and dynamic AR have been monitored in neurocritical care to aid prognostication and contribute to individualizing optimal CPP targets in patients. Theoretically, failure of cerebral AR is associated with poor outcomes in various acute neurological diseases. Continuous bedside monitoring of autoregulation is now feasible and should be considered as a part of multimodality monitoring including measurement of pressure reactivity. A previous study documented that REG (REGx) and ICP (PRx) has high correlation in order to detect the lower limit of CBF AR. The fundamental relationships between SAP, vessel tone, cerebral blood volume and ICP form the basis for the pressure reactivity index (PRx). PRx is analogous to other time domain AR indices and is calculated as the continuous correlation between thirty consecutive time-averaged (10 s) SAP and ICP values. A positive index (positive correlation) implies impaired passive CBF AR, while a negative index (inverse correlation) implies intact, active AR. The utility and feasibility of REG as a monitoring modality is previously demonstrated and validated as a reflection of cerebrovascular reactivity. The bioimpedance amplifier was used previously at Walter Reed Army Institute of Research (WRAIR) and Naval Medical Research Center (Silver Spring, MD); and has an FDA safety clearance. It is expected that REG can predict evolving vasospasm and expanding intracranial bleeding amongst several other clinical applications.

Conditions

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Intracranial Pressure Increase Cerebral Edema

Keywords

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neuromonitoring intracranial pressure (ICP) cerebral blood flow autoregulation Rheoencephalography (REG) noninvasive neuromonitoring cerebral edema autoregulation Cerebral Perfusion Pressure Pressure reactivity index

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Intact fronto-temporal area
* Intact lower arm area
* Clinical suspicion of elevated intracranial pressure

Exclusion Criteria

* N/A

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Louis Cannizzaro, MD

Role: PRINCIPAL_INVESTIGATOR

Ochsner

Locations

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Ochsner Health System

New Orleans, Louisiana, United States

Site Status

Countries

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United States

References

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Steiner LA, Andrews PJ. Monitoring the injured brain: ICP and CBF. Br J Anaesth. 2006 Jul;97(1):26-38. doi: 10.1093/bja/ael110. Epub 2006 May 12.

Reference Type BACKGROUND

PMID: 16698860 (View on PubMed)

Donnelly J, Aries MJ, Czosnyka M. Further understanding of cerebral autoregulation at the bedside: possible implications for future therapy. Expert Rev Neurother. 2015 Feb;15(2):169-85. doi: 10.1586/14737175.2015.996552.

Reference Type BACKGROUND

PMID: 25614952 (View on PubMed)

MCHENRY LC Jr. RHEOENCEPHALOGRAPHY: A CLINICAL APPRAISAL. Neurology. 1965 Jun;15:507-17. doi: 10.1212/wnl.15.6.507. No abstract available.

Reference Type BACKGROUND

PMID: 14312772 (View on PubMed)

Traczewski W, Moskala M, Kruk D, Goscinski I, Szwabowska D, Polak J, Wielgosz K. The role of computerized rheoencephalography in the assessment of normal pressure hydrocephalus. J Neurotrauma. 2005 Jul;22(7):836-43. doi: 10.1089/neu.2005.22.836.

Reference Type BACKGROUND

PMID: 16004585 (View on PubMed)

Bodo M, Simovic M, Pearce F, Ahmed A, Armonda R. Correlation of rheoencephalogram and intracranial pressure: results of a rat study. Physiol Meas. 2015 Oct;36(10):N115-26. doi: 10.1088/0967-3334/36/10/N115. Epub 2015 Sep 3.

Reference Type BACKGROUND

PMID: 26334594 (View on PubMed)

Le Roux P, Menon DK, Citerio G, Vespa P, Bader MK, Brophy GM, Diringer MN, Stocchetti N, Videtta W, Armonda R, Badjatia N, Boesel J, Chesnut R, Chou S, Claassen J, Czosnyka M, De Georgia M, Figaji A, Fugate J, Helbok R, Horowitz D, Hutchinson P, Kumar M, McNett M, Miller C, Naidech A, Oddo M, Olson D, O'Phelan K, Provencio JJ, Puppo C, Riker R, Robertson C, Schmidt M, Taccone F; Neurocritical Care Society; European Society of Intensive Care Medicine. Consensus summary statement of the International Multidisciplinary Consensus Conference on Multimodality Monitoring in Neurocritical Care : a statement for healthcare professionals from the Neurocritical Care Society and the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Sep;40(9):1189-209. doi: 10.1007/s00134-014-3369-6. Epub 2014 Aug 20.

Reference Type BACKGROUND

PMID: 25138226 (View on PubMed)

Harary M, Dolmans RGF, Gormley WB. Intracranial Pressure Monitoring-Review and Avenues for Development. Sensors (Basel). 2018 Feb 5;18(2):465. doi: 10.3390/s18020465.

Reference Type BACKGROUND

PMID: 29401746 (View on PubMed)

Strandgaard S, Paulson OB. Cerebral autoregulation. Stroke. 1984 May-Jun;15(3):413-6. doi: 10.1161/01.str.15.3.413. No abstract available.

Reference Type BACKGROUND

PMID: 6374982 (View on PubMed)

PEREZ-BORJA C, MEYER JS. A CRITICAL EVALUATION OF RHEOENCEPHALOGRAPHY IN CONTROL SUBJECTS AND IN PROVEN CASES OF CEREBROVASCULAR DISEASE. J Neurol Neurosurg Psychiatry. 1964 Feb;27(1):66-72. doi: 10.1136/jnnp.27.1.66. No abstract available.

Reference Type BACKGROUND

PMID: 14123928 (View on PubMed)

Bodo M, Pearce FJ, Armonda RA. Cerebrovascular reactivity: rat studies in rheoencephalography. Physiol Meas. 2004 Dec;25(6):1371-84. doi: 10.1088/0967-3334/25/6/003.

Reference Type BACKGROUND

PMID: 15712716 (View on PubMed)

Bodo M, Pearce FJ, Montgomery LD, Rosenthal M, Kubinyi G, Thuroczy G, Braisted J, Forcino D, Morrissette C, Nagy I. Measurement of brain electrical impedance: animal studies in rheoencephalography. Aviat Space Environ Med. 2003 May;74(5):506-11.

Reference Type BACKGROUND

PMID: 12751577 (View on PubMed)

Bodo M, Pearce FJ, Baranyi L, Armonda RA. Changes in the intracranial rheoencephalogram at lower limit of cerebral blood flow autoregulation. Physiol Meas. 2005 Apr;26(2):S1-17. doi: 10.1088/0967-3334/26/2/001. Epub 2005 Mar 29.

Reference Type BACKGROUND

PMID: 15798222 (View on PubMed)

Bodo M, Szebeni J, Baranyi L, Savay S, Pearce FJ, Alving CR, Bunger R. Cerebrovascular involvement in liposome-induced cardiopulmonary distress in pigs. J Liposome Res. 2005;15(1-2):3-14. doi: 10.1081/lpr-64523.

Reference Type BACKGROUND

PMID: 16194924 (View on PubMed)

Armonda RA, Bell RS, Vo AH, Ling G, DeGraba TJ, Crandall B, Ecklund J, Campbell WW. Wartime traumatic cerebral vasospasm: recent review of combat casualties. Neurosurgery. 2006 Dec;59(6):1215-25; discussion 1225. doi: 10.1227/01.NEU.0000249190.46033.94.

Reference Type BACKGROUND

PMID: 17277684 (View on PubMed)

Le Roux P, Menon DK, Citerio G, Vespa P, Bader MK, Brophy GM, Diringer MN, Stocchetti N, Videtta W, Armonda R, Badjatia N, Boesel J, Chesnut R, Chou S, Claassen J, Czosnyka M, De Georgia M, Figaji A, Fugate J, Helbok R, Horowitz D, Hutchinson P, Kumar M, McNett M, Miller C, Naidech A, Oddo M, Olson D, O'Phelan K, Provencio JJ, Puppo C, Riker R, Robertson C, Schmidt M, Taccone F. Consensus summary statement of the International Multidisciplinary Consensus Conference on Multimodality Monitoring in Neurocritical Care: a statement for healthcare professionals from the Neurocritical Care Society and the European Society of Intensive Care Medicine. Neurocrit Care. 2014 Dec;21 Suppl 2(Suppl 2):S1-26. doi: 10.1007/s12028-014-0041-5.

Reference Type BACKGROUND

PMID: 25208678 (View on PubMed)

Other Identifiers

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2018.149

Identifier Type: -

Identifier Source: org_study_id

Noninvasive Monitoring of Cerebral Blood Flow Autoregulation

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Ochsner Health System

Responsible Party

Principal Investigators

Louis Cannizzaro, MD

Locations

Ochsner Health System

Countries

References

Steiner LA, Andrews PJ. Monitoring the injured brain: ICP and CBF. Br J Anaesth. 2006 Jul;97(1):26-38. doi: 10.1093/bja/ael110. Epub 2006 May 12.

Donnelly J, Aries MJ, Czosnyka M. Further understanding of cerebral autoregulation at the bedside: possible implications for future therapy. Expert Rev Neurother. 2015 Feb;15(2):169-85. doi: 10.1586/14737175.2015.996552.

MCHENRY LC Jr. RHEOENCEPHALOGRAPHY: A CLINICAL APPRAISAL. Neurology. 1965 Jun;15:507-17. doi: 10.1212/wnl.15.6.507. No abstract available.

Traczewski W, Moskala M, Kruk D, Goscinski I, Szwabowska D, Polak J, Wielgosz K. The role of computerized rheoencephalography in the assessment of normal pressure hydrocephalus. J Neurotrauma. 2005 Jul;22(7):836-43. doi: 10.1089/neu.2005.22.836.

Bodo M, Simovic M, Pearce F, Ahmed A, Armonda R. Correlation of rheoencephalogram and intracranial pressure: results of a rat study. Physiol Meas. 2015 Oct;36(10):N115-26. doi: 10.1088/0967-3334/36/10/N115. Epub 2015 Sep 3.

Harary M, Dolmans RGF, Gormley WB. Intracranial Pressure Monitoring-Review and Avenues for Development. Sensors (Basel). 2018 Feb 5;18(2):465. doi: 10.3390/s18020465.

Strandgaard S, Paulson OB. Cerebral autoregulation. Stroke. 1984 May-Jun;15(3):413-6. doi: 10.1161/01.str.15.3.413. No abstract available.

PEREZ-BORJA C, MEYER JS. A CRITICAL EVALUATION OF RHEOENCEPHALOGRAPHY IN CONTROL SUBJECTS AND IN PROVEN CASES OF CEREBROVASCULAR DISEASE. J Neurol Neurosurg Psychiatry. 1964 Feb;27(1):66-72. doi: 10.1136/jnnp.27.1.66. No abstract available.

Bodo M, Pearce FJ, Armonda RA. Cerebrovascular reactivity: rat studies in rheoencephalography. Physiol Meas. 2004 Dec;25(6):1371-84. doi: 10.1088/0967-3334/25/6/003.

Bodo M, Pearce FJ, Montgomery LD, Rosenthal M, Kubinyi G, Thuroczy G, Braisted J, Forcino D, Morrissette C, Nagy I. Measurement of brain electrical impedance: animal studies in rheoencephalography. Aviat Space Environ Med. 2003 May;74(5):506-11.

Bodo M, Pearce FJ, Baranyi L, Armonda RA. Changes in the intracranial rheoencephalogram at lower limit of cerebral blood flow autoregulation. Physiol Meas. 2005 Apr;26(2):S1-17. doi: 10.1088/0967-3334/26/2/001. Epub 2005 Mar 29.

Bodo M, Szebeni J, Baranyi L, Savay S, Pearce FJ, Alving CR, Bunger R. Cerebrovascular involvement in liposome-induced cardiopulmonary distress in pigs. J Liposome Res. 2005;15(1-2):3-14. doi: 10.1081/lpr-64523.

Armonda RA, Bell RS, Vo AH, Ling G, DeGraba TJ, Crandall B, Ecklund J, Campbell WW. Wartime traumatic cerebral vasospasm: recent review of combat casualties. Neurosurgery. 2006 Dec;59(6):1215-25; discussion 1225. doi: 10.1227/01.NEU.0000249190.46033.94.

Related Links

Other Identifiers

2018.149