Intracranial Pressure IncreaseNCT04730713
The Morphology and Parameter Estimation of Cranial Ultrasound Spectrum Based on Cerebral Artery
An observational study of Intracranial Pressure Increase, run by Xiangya Hospital of Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracranial Pressure Increase
- What is being tested?
- The morphology and parameters of cranial ultrasound spectrum based on cerebral artery
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age over 18 years old, <85 Years old; patients who need lumbar puncture.
Who may be able to join
- 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.
Who cannot join
- Age <18 years old;
- Pregnancy;
- The condition of the temporal window is limited and the image cannot be obtained;
- The frequency spectrum of bilateral cerebral arteries shows stenosis;
- Patients with cerebral artery stenosis
- Patients who have not obtained informed consent;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
medical Ethics committee of Xiangya Hospital Central South University
Changsha, Hunan, 410008
xiao, 86-731-84327919, xyyyllwyh@126.com
About this study
- Observe the changes of TCD/TCCD spectrum shape before and after lumbar puncture in patients with severe neurological disease.
- Discuss the TCD/TCCD spectrum shape and parameters of cerebral arteries and neurocritical patients Correlation of intracranial pressure.
Read the 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
- Conditions
- Intracranial Pressure Increase
- Being tested
- The morphology and parameters of cranial ultrasound spectrum based on cerebral artery
- Keywords
- Transcranial Doppler（TCD）,Intracranial pressure(ICP)
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The morphology and parameters of cranial ultrasound spectrum based on cerebral arteryDevice
Also called transcranial Doppler
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The morphology and parameters of cranial ultrasound spectrum based on cerebral artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January 26, 2021 to December 30, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start26 Jan 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Pressure IncreaseStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- li na li na, PhD Tutor, Study chair, Department of Critical Care Medicine, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730713
- Sponsor's protocol ID
- 202101009
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Morphology and Parameter Estimation of Cranial Ultrasound Spectrum Based on Cerebral Artery
- ClinicalTrials.gov ID
- NCT04730713
- Acronym / sponsor ID
- 202101009
- Conditions
- Intracranial Pressure Increase
- Keywords
- Transcranial Doppler（TCD）,Intracranial pressure(ICP)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Observe the changes of TCD/TCCD spectrum shape before and after lumbar puncture in patients with severe neurological disease.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Admitted to the center ICU due to neurosurgery, brain dysfunction and other neurological reasons | – | Device: The morphology and parameters of cranial ultrasound spectrum based on cerebral arteryAneurysmal 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age over 18 years old, <85 Years old; patients who need lumbar puncture.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Age <18 years old;
- Pregnancy;
- The condition of the temporal window is limited and the image cannot be obtained;
- The frequency spectrum of bilateral cerebral arteries shows stenosis;
- Patients with cerebral artery stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The morphology and parameters of cranial ultrasound spectrum based on cerebral arteryAlso: transcranial DopplerSubjects 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) | Device | Admitted to the center ICU due to neurosurgery, brain dysfunction and other neurological reasons |
Primary outcome
The TCD/TCCD spectrum shape and parameters of cerebral arteries are related to the intracranial pressure of neurocritical patients
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
li na li na, PhD Tutor study chair
Department of Critical Care Medicine, Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure Increase, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact li na Zhang, PhD Tutor (86-15874875763, zln7095@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The TCD/TCCD spectrum shape and parameters of cerebral arteries are related to the intracranial pressure of neurocritical patients (time frame: January 26, 2021 to December 30, 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.