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

ConditionTraumatic Brain Injury
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Traumatic brain injury;

Received invasive ICP monitoring;

age ≥ 18 years old.

Disqualifiers

Severe eyeball / eyelid damage prevents transorbital ultrasound examination;

Allergy to ultrasound coupling agent;

Pregnant or lactating females.

Trial population

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

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

64 Participants
are divided into 1 treatment group
Group A: Patients with traumatic brain injury and invasive ICP monitoring4 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiangya Hospital of Central South University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: