- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05170295
Noninvasive Monitoring of Cerebral Blood Flow Autoregulation
December 8, 2021 updated by: Ochsner Health System
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Health System
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This study will involve patients of Neurocritical Care Department with clinical suspicion of elevated intracranial pressure.
Description
Inclusion Criteria:
- Intact fronto-temporal area
- Intact lower arm area
- Clinical suspicion of elevated intracranial pressure
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral Blood Flow Autoregulation (CBF AR)
Time Frame: through hospital admission, an average of 10 days
|
Cerebral Blood Flow Autoregulation (CBF AR) will be analyzed based on noninvasive recordings (bioimpedance) by using a dedicated software for this purpose (part of ICM+ program, incorporated into a WRAIR-made software (DataLyser)).
In this case CBF AR is called REGx.
|
through hospital admission, an average of 10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICP Elevation
Time Frame: through hospital admission, an average of 10 days
|
Morphological analysis of REG pulse waveform in order to detect ICP elevation, and establish the correlation between REGx and REG pulse waveform morphology.
|
through hospital admission, an average of 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Louis Cannizzaro, MD, Ochsner
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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:S1-26. doi: 10.1007/s12028-014-0041-5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2018
Primary Completion (Actual)
April 28, 2021
Study Completion (Actual)
April 28, 2021
Study Registration Dates
First Submitted
October 25, 2021
First Submitted That Met QC Criteria
December 8, 2021
First Posted (Actual)
December 27, 2021
Study Record Updates
Last Update Posted (Actual)
December 27, 2021
Last Update Submitted That Met QC Criteria
December 8, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018.149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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