The Morphology and Parameter Estimation of Cranial Ultrasound Spectrum Based on Cerebral Artery

1. Observe the changes of TCD/TCCD spectrum shape before and after lumbar puncture in patients with severe neurological disease.
2. Discuss the TCD/TCCD spectrum shape and parameters of cerebral arteries and neurocritical patients Correlation of intracranial pressure.

Study Overview

• Status: Unknown
• Conditions: Intracranial Pressure Increase
• Intervention / Treatment: Device: The morphology and parameters of cranial ultrasound spectrum based on cerebral artery

Detailed Description

After entering the ICU, the subjects who meet the standards will undergo a full-body physical examination and basic vital signs assessment and monitoring, which mainly include specialized examinations of the nervous system, multimodal brain function testing, respiratory system monitoring and management, hemodynamic monitoring, and APACHEⅡ Score, GCS score, and perform routine general circulation, breathing management, sedation and analgesia management, temperature management, osmotic pressure management, lumbar puncture pressure measurement

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • medical Ethics committee of Xiangya Hospital Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Age over 18 years old, <85 Years old; patients who need lumbar puncture.

Description

Inclusion Criteria:

Aneurysmal subarachnoid hemorrhage (aSAH), traumatic brain injury (TBI), acute deficiency Blood stroke (AIS), acute cerebral hemorrhage (ICH), hypoxic ischemic encephalopathy (HIE), Sepsis-associated encephalopathy (SAE), intracranial tumor surgery; older than 18 years old, <85 Years old; patients who need lumbar puncture.

Exclusion Criteria:

1. Age <18 years old;
2. Pregnancy;
3. The condition of the temporal window is limited and the image cannot be obtained;
4. The frequency spectrum of bilateral cerebral arteries shows stenosis;
5. Patients with cerebral artery stenosis
6. Patients who have not obtained informed consent;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Admitted to the center ICU due to neurosurgery, brain dysfunction and other neurological reasons; Aneurysmal subarachnoid hemorrhage (aSAH), traumatic brain injury (TBI), acute deficiency Blood stroke (AIS), acute cerebral hemorrhage (ICH), hypoxic ischemic encephalopathy (HIE), Sepsis-associated encephalopathy (SAE), intracranial tumor surgery; older than 18 years old, <85 Years old; patients who need lumbar puncture.

Device: The morphology and parameters of cranial ultrasound spectrum based on cerebral artery; Subjects who meet the standards will undergo a full-body examination and basic life after entering the ICU Sign evaluation and monitoring, mainly including nervous system specialist physical examination, multi-modal brain function testing, Respiratory system monitoring and management, hemodynamic monitoring, APACHE Ⅱ score, GCS score, and routine general circulation, respiratory management, sedation and analgesia management, temperature management, infiltration Pressure management, lumbar pressure measurement The included subjects were monitored for optic nerve sheath diameter, TCD/TCCD before and after lumbar puncture, and recorded spectrum morphology: normal, high resistance state, ischemic topic, congestion state, spasticity, nail wave/oscillating wave state, S1S2 fusion high point state, and recording at the same time Parameters: systolic flow rate (Vs) Shu Tensile blood flow velocity (Vd), average blood flow velocity (Vm), pulsatility index (PI), impedance Index (RI); Other Names: transcranial Doppler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The TCD/TCCD spectrum shape and parameters of cerebral arteries are related to the intracranial pressure of neurocritical patients	The change of TCD/TCCD spectrum shape can qualitatively evaluate ICP. The intracranial pressure is qualitatively determined by spectrum morphology to help clinicians quickly assess intracranial pressure and guide treatment. Accurately identify the normal shape of the spectrum, the state of high resistance, the state of ischemia, the state of congestion, the state of spasticity, the state of nail wave/oscillating wave, and the state of S1S2 fusion high tip. Discuss the correlation between spectrum shape and waist piercing ICP.	January 26, 2021 to December 30, 2022

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Investigators: Study Chair: li na li na, PhD Tutor, Department of Critical Care Medicine, Central South University

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 31, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Transcranial Doppler（TCD）,Intracranial pressure(ICP)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension
• Other Study ID Numbers: 202101009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No