NCT04730713

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

January 25, 2021

Last Update Submit

January 31, 2021

Conditions

Keywords

Transcranial Doppler(TCD),Intracranial pressure(ICP)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

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)

Also known as: transcranial Doppler
Admitted to the center ICU due to neurosurgery, brain dysfunction and other neurological reasons

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

medical Ethics committee of Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

EchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • li na li na, PhD Tutor

    Department of Critical Care Medicine, Central South University

    STUDY CHAIR

Central Study Contacts

li na Zhang, PhD Tutor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 29, 2021

Study Start

January 26, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations