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

NCT07151287 | Not Yet Recruiting

• 1 other identifier: Ultrasound-ICP
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Brain Injury

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Sensitivity and specificity of TCCD

  Sensitivity and specificity of diagnosing intracranial hypertension using TCCD

  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

  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

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

Secondary Outcomes (1)

• Pearson correlation coefficient between ultrasound metrics and invasive ICP

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

Study Arms (1)

Patients with traumatic brain injury and invasive ICP monitoring

Patients with traumatic brain injury and invasive ICP monitoring.

Diagnostic Test: TCCD; Diagnostic Test: ONSD; Diagnostic Test: ODH; Diagnostic Test: Invasive ICP

Interventions

TCCD DIAGNOSTIC_TEST

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

Patients with traumatic brain injury and invasive ICP monitoring

ONSD DIAGNOSTIC_TEST

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

Patients with traumatic brain injury and invasive ICP monitoring

ODH DIAGNOSTIC_TEST

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

Patients with traumatic brain injury and invasive ICP monitoring

Invasive ICP DIAGNOSTIC_TEST

Patients receive invasive assessments of ICP.

Patients with traumatic brain injury and invasive ICP monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study selects patients admitted to the neurosurgical intensive care unit of Central South University Xiangya Hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Ziyuan Liu, M.D.

CONTACT

86-151-1137-3960; ethmery@yeah.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Neurotrauma and Neurointensive Care Group

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: September 3, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share