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Recruiting NCT07222826

Non-invasive Intracranial Pressure Estimation by Measurement of the Occlusion Pressure of the Isolated Periorbital Vein

No phase Interventional Intracranial Pressure Intracranial Pressure Changes

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: CPMX3.
Who it may be relevant to
Registry conditions: Intracranial Pressure, Intracranial Pressure Changes. 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
United States
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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Official title

Non-invasive Intracranial Pressure Estimation by Measurement of the Occlusion Pressure of the Isolated Periorbital Vein (NICE-ICP)

Overview

Elevated intracranial pressure is a common complication of brain injury which means that the pressure within the skull rises above normal levels. The negative impact of increased intracranial pressure (ICP) on the prognosis of patients has been strongly shown in numerous studies and ICP-based treatment is associated with an important reduction of risk of death. Invasive ICP measurement methods are nowadays a standard of care in severe brain injury. The two available ways of measuring ICP require neurosurgical procedure to implant a catheter and probes within the brain and present risks and complications for the patient, such as infections and intracranial bleeding. In addition, invasive recording of ICP requires neurosurgical expertise and intensive care unit (ICU) facilities, limiting the application of ICP measurements to patients of the acute neuro-ICU (neuro-Intensive Care Unit) with acute brain damage requiring close surveillance to prevent further deterioration of neural tissue and disability. Non-invasive ICP monitoring benefits include no risk of complications seen in invasive monitoring, helping in deciding which patient needs invasive ICP monitoring, and providing ongoing long-term measurements of ICP without having to insert a new device every time. Although many non-invasive ICP measurement methods have been explored, to date, none of them have shown clinical success or usefulness. One under-explored window to ICP is the orbital vein, a small blood vessel located near your eye, which we think could provide a direct link to the intracranial pressure. The study device, called the CPMX3 system, is a non-invasive method to measure pressure in a superficial periorbital vein.

Interventions

  • Device CPMX3
    CPMX3 periorbital vein pressure measurement

Primary outcome measures

  • Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported adverse events [Time frame: up to 7 days]
  • Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported Device Deficiencies (DDs) [Time frame: Up to 7 days]
  • Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported Serious Adverse Device Effects (SADEs) [Time frame: Up to 7 Days]
  • Preliminary accuracy of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, measured in mmHg [Time frame: up to 7 days]
Secondary outcome measures (2)
  • Feasibility of finding and compressing the target periorbital vein as reported by the investigator using a visual analog scale 0 to 3 [Time frame: up to 7 days]
  • The tolerability of the non-invasive measurement process, evaluated via a dedicated patient questionnaire on patient comfort [Time frame: up to 7 days]

Eligibility criteria

Inclusion criteria

  • Male or female
  • Age > 18
  • Equipped with an invasive ICP monitor as part of standard of care

Exclusion criteria

  • Presence of facial and/or skull trauma that could hinder placement of the pneumatic mask or contraindicate ultrasound on the forehead
  • History of recent cranial surgery or hemicraniectomy
  • Active bleeding (proven or suspected)
  • History or known pathological condition or injury linked to the orbital socket influencingvenous outflow (e.g. Grave disease, tumor, inflammation, trauma, glaucoma, etc.)
  • History, or known vein stenosis in ophthalmic veins/cavernous sinus
  • Any other condition that would interfere with measurement technique and routine clinical care according to the judgment of the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Baylor College of Medicine — Houston

Identifiers

NCT: NCT07222826 · NICE-ICP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗