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

• Conditions: Intracranial Pressure Increase
• Interventions: Device: The morphology and parameters of cranial ultrasound spectrum based on cerebral artery

• Registration Number: NCT04730713
• Lead Sponsor: Xiangya Hospital of Central South University

Brief 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.

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 Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Study Start: 2021-01-26
• Study First Posted: 2021-01-29
• Last Update Submitted: 2021-01-31
• Last Update Posted: 2021-02-02
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Admitted to the center ICU due to neurosurgery, brain dysfunction and other neurological reasons	The morphology and parameters of cranial ultrasound spectrum based on cerebral artery	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.

Primary Outcome Measures

Name	Time	Method
The TCD/TCCD spectrum shape and parameters of cerebral arteries are related to the intracranial pressure of neurocritical patients	January 26, 2021 to December 30, 2022	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.

Trial Locations

Locations (1)

medical Ethics committee of Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China