Multimodal Monitoring of Cerebral Autoregulation After Pediatric Brain Injury

NCT04242602 | Completed

• 1 other identifier: STU 042018-056
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Brain Injuries; Brain Injury, Vascular

Outcome Measures

Primary Outcomes (8)

• Transfer Function Analysis

  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.

  Day 1 post injury

• Transfer Function Analysis

  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.

  Day 3 post injury

• Transfer Function Analysis

  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.

  Day 5 post injury

• Transfer Function Analysis

  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.

  Day 7 post injury

• Transfer Function Analysis

  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.

  Day 10 post injury

• Wavelet Coherence Analysis

  Wavelet coherence uses phase, gain and coherence to determine a relationship between the two waveforms values MAP/CPP and SctO2.

  Day 10 post injury

• Change in Glasgow Outcome Scale Extended-Pediatrics (GOSEP) score

  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.

  6 months post discharge.

• Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score

  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.

  6 months post discharge.

Study Arms (2)

Experimental group

Subject with TBI with arterial lines and NIRS monitoring

Device: Transcranial Doppler

Control group

Subject without TBI with arterial lines and NIRS monitoring

Device: Transcranial Doppler

Interventions

Transcranial Doppler DEVICE

Record flow velocity tracing of middle cerebral artery using a transcranial doppler.

Control group; Experimental group

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children 1-18 years of age with acute TBI admitted to the pediatric intensive care unit.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas at Arlington: collaborator
• Southern Methodist University: collaborator
• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Children's Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries; Cerebrovascular Trauma

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Darryl Miles

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: January 27, 2020
• Study Start: November 6, 2018
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)