An observational study in Traumatic Brain Injury, sponsored by Xiangya Hospital of Central South University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Xiangya Hospital of Central South University · Observational
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.
1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.
This study's planned enrollment of 64 is below the median of 118 across 562 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Xiangya Hospital of Central South University is the lead sponsor of 170 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study selects patients admitted to the neurosurgical intensive care unit of Central South University Xiangya Hospital.
Exclusion Criteria:
Patients with traumatic brain injury and invasive ICP monitoring.
Diagnostic Test: TCCD · Diagnostic Test: ONSD · Diagnostic Test: ODH · Diagnostic Test: Invasive ICP
Patients receive non-invasive assessments of TCCD using bedside ultrasound.
Patients receive non-invasive assessments of ONSD using bedside ultrasound.
Patients receive non-invasive assessments of ODH using bedside ultrasound.
Patients receive invasive assessments of ICP.
Sensitivity and specificity of TCCD
Sensitivity and specificity of diagnosing intracranial hypertension using TCCD
Time frame: 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
Time frame: 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
Time frame: Day 0 (when invasive ICP probe is implanted) to day 10
Pearson correlation coefficient between ultrasound metrics and invasive ICP
Pearson correlation coefficient between metrics from bedside ultrasound and invasive ICP
Time frame: Day 0 (when invasive ICP probe is implanted) to day 10
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Xiangya Hospital of Central South University