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Набор скоро начнётся NCT05977335

Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)

— Наблюдательное Autonomic Dysfunction Orthostatic Intolerance

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: Autonomic Function Testing.
Кому может быть актуально
Состояния в реестре: Autonomic Dysfunction, Orthostatic Intolerance. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Background: The investigational device, "Task Force® CORE" (TFC, CNSystems Medizintechnik GmbH, Graz, Austria) together with the "Task Force® CARDIO" (TFCARDIO, CNSystems Medizintechnik GmbH, Graz, Austria) medical device software, is a new CE-marked medical device for continuous non-invasive determination of blood pressure (BP), cardiac output (CO) and derived parameters based on the well established CNAP® (continuous non-invasive arterial pressure) technology by CNSystems. Aim: The primary aim of this prospective, method comparison, open study is data acquisition for the performance evaluation of the TFC during autonomic function testing in comparison with an clinically accepted reference method. Setting: The setting of the clinical investigation will be the autonomic function testing laboratory at the Department of Neurology, the University Hospital Center Zagreb. Inclusion criteria: Patients who are over 18 years and who provide written informed consent. Sample size: The study has an calculated sample size of 70 patients. Considering a drop-out rate of 5%, a total of 75 patients will be included. Statistics: Descriptive statistics, values for the percentage error and correlation estimates will be derived. Furthermore, scatterplot, Bland-Altman analysis, concordance analysis of parameter changes and further comparative statistics will be performed.

Вмешательства

  • Диагностический тест Autonomic Function Testing
    Autonomic Function Testing (AFT) includes Valsalva Manoever, Deep Breathing Test, and Head-up Tilt Table Testing.

Первичные конечные точки

  • Agreement of blood pressure between investigational and reference device. [Срок оценки: The agreement is calculated for the 5 minutes supine baseline period]
  • Agreement of blood pressure between investigational and reference device. [Срок оценки: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver]
  • Agreement of blood pressure between investigational and reference device. [Срок оценки: The agreement is calculated for 90 seconds Deep Breathing period]
  • Agreement of blood pressure between investigational and reference device. [Срок оценки: The agreement is calculated for 10 minutes head-up tilt table test period]
  • Agreement of heart rate between investigational and reference device. [Срок оценки: The agreement is calculated for the 5 minutes supine baseline period]
  • Agreement of heart rate between investigational and reference device. [Срок оценки: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver]
  • Agreement of heart rate between investigational and reference device. [Срок оценки: The agreement is calculated for 90 seconds Deep Breathing period]
  • Agreement of heart rate between investigational and reference device. [Срок оценки: The agreement is calculated for 10 minutes head-up tilt table test period]
  • Agreement of cardiac output between investigational and reference device. [Срок оценки: The agreement is calculated for the 5 minutes supine baseline period]
  • Agreement of cardiac output between investigational and reference device. [Срок оценки: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver]

Критерии участия

Критерии включения

  • Adult patients (patients aged ≥ 18 years)
  • Patients giving written informed consent to participate in the study.
  • Patients with intact perfusion of both hands evidenced by a positive Allen's test.
  • Patients with orthostatic intolerance will be included

Критерии исключения

  • Patients with vascular implants at the sites of non-invasive BP measurement (fingers or upper arms)
  • Very low perfusion in the periphery
  • Arterial vascular diseases (arteriosclerosis, Raynaud's syndrome, endarteritis obliterans, collagenosis, severely advanced vascular diseases (PAOD))
  • Patients with significant edema in the fingers
  • Patients with atrial fibrillation
  • Patients with valvular disease of grade 2 or above
  • Patients with ventricular assist devices
  • Subjects not passing the Allen's test for both hands.
  • Patients with a large lateral difference in BP (> 15 mmHg for systolic BP and/or >10 mmHg for diastolic BP) or with same arm measurement differences > 10 mmHg in systolic or diastolic BP during assessment of lateral differences

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05977335 · AFTs Task Force® CORE/CARD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗