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Multimodal Monitoring of Cerebral Autoregulation After Pediatric Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242602
Recruitment Status : Active, not recruiting
First Posted : January 27, 2020
Last Update Posted : April 9, 2020
Sponsor:
Collaborators:
The University of Texas at Arlington
Southern Methodist University
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

Various methods have been studied to evaluate autoregulation. However, there is currently no universally accepted technique to assess integrity of the cerebral autoregulation neurovascular system. In the last decade, significant progress has been achieved in developing methods to assess cerebral autoregulation by quantifying cross-correlation between spontaneous oscillations in CBF or oxygenation and similar oscillations in arterial blood pressure.

In this study the investigators will analyze the relationship between spontaneous fluctuations in mean arterial blood pressure and cerebral blood flow velocity or cerebral regional oxygenation to investigate two novel methods for measuring cerebral autoregulation, Transfer Function Analysis and Wavelet Coherence after acute pediatric brain injury.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Brain Injuries Brain Injury, Vascular Device: Transcranial Doppler Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multimodal Monitoring of Cerebral Autoregulation After Pediatric Brain Injury
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Study Subjects Device: Transcranial Doppler
Record flow velocity tracing of middle cerebral artery using a transcranial doppler.




Primary Outcome Measures :
  1. Transfer Function Analysis [ Time Frame: Day 1 post injury ]

    The transfer function has three components:

    I. Gain: This measures the magnitude of transmission of MAP oscillations to CBFv. Effectively, a functional dCA system dampens the strength of transmitted oscillations resulting in a lower gain value. A higher gain value is therefore suggestive of impaired autoregulation.

    II. Phase is a "time delay" in degrees measured between the two waveforms. Absence of autoregulation would result in both MAP and CBFV changing at the same time. This would be measured as a 0°phase shift. Hence, a non-zero phase shift indicates intact autoregulation and counter-regulation of CBFV in response to changes in MAP.

    III. Coherence:This provides a measure of association between the two waves at difference frequencies. Coherence varies between 0 and 1, similar to a correlation coefficient it expresses the fraction of MAP linearly associated with CBFv. Gain, phase, and coherence will be aggregated to get the transfer function analysis.


  2. Transfer Function Analysis [ Time Frame: Day 3 post injury ]

    The transfer function has three components:

    I. Gain: This measures the magnitude of transmission of MAP oscillations to CBFv. Effectively, a functional dCA system dampens the strength of transmitted oscillations resulting in a lower gain value. A higher gain value is therefore suggestive of impaired autoregulation.

    II. Phase is a "time delay" in degrees measured between the two waveforms. Absence of autoregulation would result in both MAP and CBFV changing at the same time. This would be measured as a 0°phase shift. Hence, a non-zero phase shift indicates intact autoregulation and counter-regulation of CBFV in response to changes in MAP.

    III. Coherence:This provides a measure of association between the two waves at difference frequencies. Coherence varies between 0 and 1, similar to a correlation coefficient it expresses the fraction of MAP linearly associated with CBFv. Gain, phase, and coherence will be aggregated to get the transfer function analysis.


  3. Transfer Function Analysis [ Time Frame: Day 5 post injury ]

    The transfer function has three components:

    I. Gain: This measures the magnitude of transmission of MAP oscillations to CBFv. Effectively, a functional dCA system dampens the strength of transmitted oscillations resulting in a lower gain value. A higher gain value is therefore suggestive of impaired autoregulation.

    II. Phase is a "time delay" in degrees measured between the two waveforms. Absence of autoregulation would result in both MAP and CBFV changing at the same time. This would be measured as a 0°phase shift. Hence, a non-zero phase shift indicates intact autoregulation and counter-regulation of CBFV in response to changes in MAP.

    III. Coherence:This provides a measure of association between the two waves at difference frequencies. Coherence varies between 0 and 1, similar to a correlation coefficient it expresses the fraction of MAP linearly associated with CBFv. Gain, phase, and coherence will be aggregated to get the transfer function analysis.


  4. Transfer Function Analysis [ Time Frame: Day 7 post injury ]

    The transfer function has three components:

    I. Gain: This measures the magnitude of transmission of MAP oscillations to CBFv. Effectively, a functional dCA system dampens the strength of transmitted oscillations resulting in a lower gain value. A higher gain value is therefore suggestive of impaired autoregulation.

    II. Phase is a "time delay" in degrees measured between the two waveforms. Absence of autoregulation would result in both MAP and CBFV changing at the same time. This would be measured as a 0°phase shift. Hence, a non-zero phase shift indicates intact autoregulation and counter-regulation of CBFV in response to changes in MAP.

    III. Coherence:This provides a measure of association between the two waves at difference frequencies. Coherence varies between 0 and 1, similar to a correlation coefficient it expresses the fraction of MAP linearly associated with CBFv. Gain, phase, and coherence will be aggregated to get the transfer function analysis.


  5. Transfer Function Analysis [ Time Frame: Day 10 post injury ]

    The transfer function has three components:

    I. Gain: This measures the magnitude of transmission of MAP oscillations to CBFv. Effectively, a functional dCA system dampens the strength of transmitted oscillations resulting in a lower gain value. A higher gain value is therefore suggestive of impaired autoregulation.

    II. Phase is a "time delay" in degrees measured between the two waveforms. Absence of autoregulation would result in both MAP and CBFV changing at the same time. This would be measured as a 0°phase shift. Hence, a non-zero phase shift indicates intact autoregulation and counter-regulation of CBFV in response to changes in MAP.

    III. Coherence:This provides a measure of association between the two waves at difference frequencies. Coherence varies between 0 and 1, similar to a correlation coefficient it expresses the fraction of MAP linearly associated with CBFv. Gain, phase, and coherence will be aggregated to get the transfer function analysis.


  6. Wavelet Coherence Analysis [ Time Frame: Day 10 post injury ]
    Wavelet coherence uses phase, gain and coherence to determine a relationship between the two waveforms values MAP/CPP and SctO2.

  7. Change in Glasgow Outcome Scale Extended-Pediatrics (GOSEP) score [ Time Frame: 6 months post discharge. ]
    The 8-point Glasgow Outcome Scale Extended-Pediatrics (GOSEP) will be used to assess change in neurologic function from baseline. The GOSEP is composed of 3 parts: eye opening, best motor response, and best verbal response. Eye opening is measure 1-4, the higher the category, the better outcome. Best motor response is measured as 1-6, the higher the score, the better outcome. Best verbal response is measured as 1-5, the higher the score, the better outcome. All 3 categories are summed together to equal a total GOSEP score. The higher the overall score, the better potential outcome.

  8. Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score [ Time Frame: 6 months post discharge. ]
    Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) a validated tool to measure domains of daily activities, mobility, social/cognitive function and responsibility from birth through 18 years. It will be used to assess change from baseline.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 28 days-18 years admitted to the PICU at Children's Medical Center Dallas
  • Acute presentation (< 24 hour) onset of neurologic injury
  • Acute neurologic injury can be due to any of the following mechanisms:

    • Severe accidental or abusive traumatic brain injury
    • Severe encephalopathy secondary to cardiac arrest
    • Spontaneous intracranial hemorrhage
    • Status epilepticus
    • Stroke
  • Presence of or pending placement of invasive indwelling arterial line for stand medical care
  • Any patient with an ICP monitor placed as standard of care

Exclusion Criteria:

  • Patients without an arterial line placed as standard of care
  • Patients unable to cooperate with wearing a TCD headpiece device
  • Expected death within 24-48 hours
  • Inability to place NIRS probes or insonate TCD signal due to massive facial or cranial injury
  • Receiving an inhalational anesthetic agent
  • Hemoglobinopathy, myoglobinemia or and hyperbilirubinemia (due to inaccurate NIRS readings)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242602


Locations
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United States, Texas
Children's Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
The University of Texas at Arlington
Southern Methodist University
Investigators
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Principal Investigator: Darryl Miles University of Texas Southwestern Medical Center
Publications:
Kochanek PM, Carney N, Adelson PD, Ashwal S, Bell MJ, Bratton S, Carson S, Chesnut RM, Ghajar J, Goldstein B, Grant GA, Kissoon N, Peterson K, Selden NR, Tasker RC, Tong KA, Vavilala MS, Wainwright MS, Warden CR; American Academy of Pediatrics-Section on Neurological Surgery; American Association of Neurological Surgeons/Congress of Neurological Surgeons; Child Neurology Society; European Society of Pediatric and Neonatal Intensive Care; Neurocritical Care Society; Pediatric Neurocritical Care Research Group; Society of Critical Care Medicine; Paediatric Intensive Care Society UK; Society for Neuroscience in Anesthesiology and Critical Care; World Federation of Pediatric Intensive and Critical Care Societies. Guidelines for the acute medical management of severe traumatic brain injury in infants, children, and adolescents--second edition. Pediatr Crit Care Med. 2012 Jan;13 Suppl 1:S1-82. doi: 10.1097/PCC.0b013e31823f435c. Erratum in: Pediatr Crit Care Med. 2012 Mar;13(2):252.

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04242602    
Other Study ID Numbers: STU042018-056
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Cerebrovascular Trauma
Vascular System Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases