Diagnosis of Intracranial Hypertension Using TCCD, ONSD and ODH by Bedside Ultrasound

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07151287

Enrollment

Registered

2025-09-03

Start date

2025-09-15

Completion date

2027-07-01

Last updated

2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury, craniocerebral trauma, brain trauma, intracranial pressure, transcranial Doppler ultrasound

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTTCCD

Patients receive non-invasive assessments of TCCD using bedside ultrasound.

DIAGNOSTIC_TESTONSD

Patients receive non-invasive assessments of ONSD using bedside ultrasound.

DIAGNOSTIC_TESTODH

Patients receive non-invasive assessments of ODH using bedside ultrasound.

DIAGNOSTIC_TESTInvasive ICP

Patients receive invasive assessments of ICP.

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Traumatic brain injury; * Received invasive ICP monitoring; * age ≥ 18 years old.

Exclusion criteria

* Severe eyeball / eyelid damage prevents transorbital ultrasound examination; * Allergy to ultrasound coupling agent; * Pregnant or lactating females.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and specificity of TCCD	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	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	Day 0 (when invasive ICP probe is implanted) to day 10	Sensitivity and specificity of diagnosing intracranial hypertension using ODH

Secondary

Measure	Time frame	Description
Pearson correlation coefficient between ultrasound metrics and invasive ICP	Day 0 (when invasive ICP probe is implanted) to day 10	Pearson correlation coefficient between metrics from bedside ultrasound and invasive ICP

Contacts

Primary ContactZiyuan Liu, M.D.

ethmery@yeah.net86-151-1137-3960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026