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Идёт набор NCT07222826

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

Без фазы С лечением Intracranial Pressure Intracranial Pressure Changes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: CPMX3.
Кому может быть актуально
Состояния в реестре: Intracranial Pressure, Intracranial Pressure Changes. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство CPMX3
    CPMX3 periorbital vein pressure measurement

Первичные конечные точки

  • Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported adverse events [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: up to 7 days]
Вторичные конечные точки (2)
  • Feasibility of finding and compressing the target periorbital vein as reported by the investigator using a visual analog scale 0 to 3 [Срок оценки: up to 7 days]
  • The tolerability of the non-invasive measurement process, evaluated via a dedicated patient questionnaire on patient comfort [Срок оценки: up to 7 days]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Baylor College of Medicine — Houston

Идентификаторы

NCT: NCT07222826 · NICE-ICP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗