Меню
Идёт набор NCT05673408

NIBP Validation Study

— Наблюдательное Critical Illness

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: Philips IntelliVue X3 Patient Monitor.
Кому может быть актуально
Состояния в реестре: Critical Illness. Базовые параметры: Без ограничений · 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Non-Invasive Blood Pressure Validation Study

Обзор

The purpose of this study is to compare measurements of blood pressure (BP) between the Philips non-invasive blood pressure (NIBP) system (including NIBP cuff and portable patient monitor) and invasive radial for Subject Group 2 and 3, and radial or umbilical arterial line for neonates (A-line) in critical care patients.

Подробное описание

A multi-center, multi-phase, prospective, self-controlled, observational study.

* Phase I - A pilot phase designed for feasibility and the potential for algorithm development (enhancement). * Phase II - Pivotal Phase: At the completion of Phase I -and finalization of the algorithm (if applicable), Phase II is designed for the purpose of establishing equivalence of the Philips NIBP system with the gold standard radial or umbilical (neonates) arterial line.

Вмешательства

  • Устройство Philips IntelliVue X3 Patient Monitor
    All subjects enrolled in this study will receive one Philips non-invasive blood pressure cuff. This cuff will be connected via compatible hose to the Philips IntelliVue X3 monitor hosting the released or investigational NIBP algorithm. The invasive blood pressure from the radial arterial line will also be connected to the Philips IntelliVue X3 monitor. The Philips IntelliVue X3 monitor will in turn be connected to a laptop for data collection.

Первичные конечные точки

  • Philips NIBP System Equivalence to Radial Arterial Line [Срок оценки: Through study completion, approximately 1 year]

Критерии участия

Критерии включения

  • Patient admitted into the NICU, PICU, ICU, or OR (operating room)
  • Adult aged 18 years and older, or parent/legal guardian of minor, willing and able to understand and provide informed consent/assent
  • Indication for NIBP cuff
  • Indication for radial arterial line for Subject Group 2 and Subject Group 3, and radial or umbilical arterial line for Subject Group 1
  • Meet the following stratification criteria across the study:

Stratification (per the ISO 81060-2:2018/Amd-2:2024):

  • Subject Group 1:
  • At least 3 patients shall be <1000 g in weight
  • At least 3 patients shall be 1000 to 2000 g in weight
  • At least 3 patients shall be > 2000 g in weight
  • At least 3 patients shall be ≥ 29 days and < 1 year of age
  • At least 3 patients shall be ≥ 1 year and < 3 years of age
  • The remaining patients may be from any of the above age or weight groups in order to complete the sample size
  • A patient can be in more than one category simultaneously
  • Subject Group 2:
  • At least 30% male, 30% female
  • Limb circumference distributed as specified in ISO81060-2:2018/Amd2:2024.
  • Subject Group 3:
  • At least 30% male, 30% female
  • Limb circumference distributed as specified in ISO81060- 2:2018/Amd-2:2024.
  • At least 10% SBP ≤ 100mmHg
  • At least 10% SBP ≥ 160mmHg
  • At least 10% DBP ≤ 70mmHg
  • At least 10% DBP ≥ 85mmHg

Критерии исключения

  • Inability to place the study device appropriately due to patient's anatomy or condition
  • Known pregnancy or lactating women (self-report)
  • Patients treated with an intra-aortic balloon pump
  • Aortic and mitral regurgitation (> 2 nd degree)
  • Measurements taken in the lateral position
  • Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s)
  • If valid SBP reference measurements for lateral difference is > 15 mmHg (except for neonates with umbilical A-line)
  • If valid DBP reference measurements for lateral difference is > 10 mmHg (except for neonates with umbilical A-line)
  • At the Principal Investigator's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 5 центров
  • Mayo Clinic Jacksonville — Jacksonville
  • Wake Forest University Health Sciences — Winston-Salem
  • Oregon Health & Science University — Portland
  • University Health Women's and Children's Hospital — San Antonio
  • University of Utah — Salt Lake City

Идентификаторы

NCT: NCT05673408 · CC_MA_NIBPValidation_2022_1151

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗