Diagnosis of Intracranial Hypertension Using TCCD, ONSD and ODH by Bedside Ultrasound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TCCD, ONSD, ODH, Invasive ICP.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test TCCD
Patients receive non-invasive assessments of TCCD using bedside ultrasound. - Diagnostic test ONSD
Patients receive non-invasive assessments of ONSD using bedside ultrasound. - Diagnostic test ODH
Patients receive non-invasive assessments of ODH using bedside ultrasound. - Diagnostic test Invasive ICP
Patients receive invasive assessments of ICP.
Primary outcome measures
- Sensitivity and specificity of TCCD [Time frame: Day 0 (when invasive ICP probe is implanted) to day 10]
- Sensitivity and specificity of ONSD [Time frame: Day 0 (when invasive ICP probe is implanted) to day 10]
- Sensitivity and specificity of ODH [Time frame: Day 0 (when invasive ICP probe is implanted) to day 10]
Secondary outcome measures (1)
- Pearson correlation coefficient between ultrasound metrics and invasive ICP [Time frame: Day 0 (when invasive ICP probe is implanted) to day 10]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07151287 · Ultrasound-ICP