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

Intracranial Pressure Increase Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04730713
• Other study ID #: 202101009
• Status: Recruiting
• Start date: January 26, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2021
• Source: Xiangya Hospital of Central South University
• Contact: li na Zhang, PhD Tutor
• Phone: 86-15874875763
• Email: zln7095[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Intracranial Hypertension
• Intracranial Pressure Increase

Intervention

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 ? 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)

Locations

Country	Name	City	State
China	medical Ethics committee of Xiangya Hospital Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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