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

NCT ID: NCT07151287

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-07-01

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with traumatic brain injury and invasive ICP monitoring

Patients with traumatic brain injury and invasive ICP monitoring.

TCCD

Intervention Type: DIAGNOSTIC_TEST

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

ONSD

Intervention Type: DIAGNOSTIC_TEST

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

ODH

Intervention Type: DIAGNOSTIC_TEST

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

Invasive ICP

Intervention Type: DIAGNOSTIC_TEST

Patients receive invasive assessments of ICP.

Interventions

TCCD

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

Intervention Type: DIAGNOSTIC_TEST

ONSD

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

Intervention Type: DIAGNOSTIC_TEST

ODH

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

Intervention Type: DIAGNOSTIC_TEST

Invasive ICP

Patients receive invasive assessments of ICP.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Jinfang Liu, MD

Director of the Neurotrauma and Neurointensive Care Group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ziyuan Liu, M.D.

Role: CONTACT

ethmery@yeah.net

86-151-1137-3960

Other Identifiers

Ultrasound-ICP

Identifier Type: -

Identifier Source: org_study_id