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NCT Number: NCT07151287

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TCCD

Diagnostic Test

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

ONSD

Diagnostic Test

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

ODH

Diagnostic Test

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

Invasive ICP

Diagnostic Test

Patients receive invasive assessments of ICP.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Pearson correlation coefficient between ultrasound metrics and invasive ICP

    Time frame: Day 0 (when invasive ICP probe is implanted) to day 10

    Pearson correlation coefficient between metrics from bedside ultrasound and invasive ICP

Study contacts

Contact information is provided by the study sponsor or research team.

Ziyuan Liu, M.D.

CONTACT

[email protected]

86-151-1137-3960

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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