Traumatic Brain InjuryNCT07151287
Diagnosis of Intracranial Hypertension Using TCCD, ONSD and ODH by Bedside Ultrasound
An observational study of Traumatic Brain Injury, run by Xiangya Hospital of Central South University.
Trial summary
The goal of this observational study is to investigate several means of measuring intracranial pressure (ICP) non-invasively in patients who had head trauma and received implantation of invasive ICP monitor device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- TCCD, ONSD and ODH
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study selects patients admitted to the neurosurgical intensive care unit of Central South University Xiangya Hospital.
Who may be able to join
- Traumatic brain injury;
- Received invasive ICP monitoring;
- age ≥ 18 years old.
Who cannot join
- Severe eyeball / eyelid damage prevents transorbital ultrasound examination;
- Allergy to ultrasound coupling agent;
- Pregnant or lactating females.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to investigate several means of measuring intracranial pressure (ICP) non-invasively in patients who had head trauma and received implantation of invasive ICP monitor device. The main questions it aims to answer are:
What are the diagnostic efficacies of Transcranial Color-Coded Doppler Ultrasound (TCCD), Optic Nerve Sheath Diameter (ONSD) and Optic Disc Height (ODH) (the 3 non-invasive way of measuring ICP) compared with invasive ICP monitor? Participants will receive simultaneous non-invasive measurements of TCCD, ONSD and ODH along with during the days of invasive ICP monitoring. The data will be compared among the techniques to study the diagnostic efficacy.
- Conditions
- Traumatic Brain Injury
- Being tested
- TCCD, ONSD, ODH, Invasive ICP
- Keywords
- traumatic brain injury, craniocerebral trauma, brain trauma, intracranial pressure, transcranial Doppler ultrasound
- Medical subject headings
- Brain Injuries, Traumatic, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCCDDiagnostic test
Patients receive non-invasive assessments of TCCD using bedside ultrasound.
ONSDDiagnostic test
Patients receive non-invasive assessments of ONSD using bedside ultrasound.
ODHDiagnostic test
Patients receive non-invasive assessments of ODH using bedside ultrasound.
Invasive ICPDiagnostic test
Patients receive invasive assessments of ICP.
| Study group | Role | What they receive |
|---|---|---|
| Patients with traumatic brain injury and invasive ICP monitoring | Patients with traumatic brain injury and invasive ICP monitoring. Receives: Diagnostic Test: TCCD; Diagnostic Test: ONSD; Diagnostic Test: ODH; Diagnostic Test: Invasive ICP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of TCCD
Sensitivity and specificity of diagnosing intracranial hypertension using TCCD
Measured: Day 0 (when invasive ICP probe is implanted) to day 10
Sensitivity and specificity of ONSD
Sensitivity and specificity of diagnosing intracranial hypertension using ONSD
Measured: Day 0 (when invasive ICP probe is implanted) to day 10
Sensitivity and specificity of ODH
Sensitivity and specificity of diagnosing intracranial hypertension using ODH
Measured: Day 0 (when invasive ICP probe is implanted) to day 10
Secondary outcomes (1)
Pearson correlation coefficient between ultrasound metrics and invasive ICP
Pearson correlation coefficient between metrics from bedside ultrasound and invasive ICP
Measured: Day 0 (when invasive ICP probe is implanted) to day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinfang Liu, MD, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151287
- Sponsor's protocol ID
- Ultrasound-ICP
- Status last verified
- Sep 2025
- First submitted
- 2 Jul 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data cannot be shared publicly because of patient privacy protection. Data are available from the Xiangya Hospital Institutional Data Access / Ethics Committee for researchers who meet the criteria for access to confidential data.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Intracranial Hypertension Using TCCD, ONSD and ODH by Bedside Ultrasound
- ClinicalTrials.gov ID
- NCT07151287
- Acronym / sponsor ID
- Ultrasound-ICP
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, craniocerebral trauma, brain trauma, intracranial pressure, transcranial Doppler ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 3 Sep 2025 (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.
The goal of this observational study is to investigate several means of measuring intracranial pressure (ICP) non-invasively in patients who had head trauma and received implantation of invasive ICP monitor device. The main questions it aims to answer are:
What are the diagnostic efficacies of Transcranial Color-Coded Doppler Ultrasound (TCCD), Optic Nerve Sheath Diameter (ONSD) and Optic Disc Height (ODH) (the 3 non-invasive way of measuring ICP) compared with invasive ICP monitor? Participants will receive simultaneous non-invasive measurements of TCCD, ONSD and ODH along with during the days of invasive ICP monitoring. The data will be compared among the techniques to study the diagnostic efficacy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with traumatic brain injury and invasive ICP monitoring | – | Diagnostic Test: TCCD, Diagnostic Test: ONSD, Diagnostic Test: ODH, Diagnostic Test: Invasive ICPPatients with traumatic brain injury and invasive ICP monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study selects patients admitted to the neurosurgical intensive care unit of Central South University Xiangya Hospital.
Key inclusion criteria (3 listed)
- Traumatic brain injury;
- Received invasive ICP monitoring;
- age ≥ 18 years old.
Key exclusion criteria (3 listed)
- Severe eyeball / eyelid damage prevents transorbital ultrasound examination;
- Allergy to ultrasound coupling agent;
- Pregnant or lactating females.
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 |
|---|---|---|
| TCCDPatients receive non-invasive assessments of TCCD using bedside ultrasound. | Diagnostic test | Patients with traumatic brain injury and invasive ICP monitoring |
| ONSDPatients receive non-invasive assessments of ONSD using bedside ultrasound. | Diagnostic test | Patients with traumatic brain injury and invasive ICP monitoring |
| ODHPatients receive non-invasive assessments of ODH using bedside ultrasound. | Diagnostic test | Patients with traumatic brain injury and invasive ICP monitoring |
| Invasive ICPPatients receive invasive assessments of ICP. | Diagnostic test | Patients with traumatic brain injury and invasive ICP monitoring |
Primary outcome
Sensitivity and specificity of TCCD
Time frame: Day 0 (when invasive ICP probe is implanted) to day 10
Sensitivity and specificity of diagnosing intracranial hypertension using TCCD
Sensitivity and specificity of ONSD
Time frame: Day 0 (when invasive ICP probe is implanted) to day 10
Sensitivity and specificity of diagnosing intracranial hypertension using ONSD
Sensitivity and specificity of ODH
Time frame: Day 0 (when invasive ICP probe is implanted) to day 10
Sensitivity and specificity of diagnosing intracranial hypertension using ODH
1 secondary outcome
Pearson correlation coefficient between ultrasound metrics and invasive ICP
Time frame: Day 0 (when invasive ICP probe is implanted) to day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No. Data cannot be shared publicly because of patient privacy protection. Data are available from the Xiangya Hospital Institutional Data Access / Ethics Committee for researchers who meet the criteria for access to confidential data.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Xiangya Hospital of Central South University.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ziyuan Liu, M.D. (86-151-1137-3960, ethmery@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of TCCD (time frame: Day 0 (when invasive ICP probe is implanted) to day 10). The study lists 3 primary outcomes in all. 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 3 Sep 2025.