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Идёт набор NCT06372106

Project Mountain - Comparing SpO2 and SaO2 for Accuracy

— Наблюдательное SpO2 Nasal Alar Collapse, Bilateral Oxygen Measurement

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: SaO2 Sampling.
Кому может быть актуально
Состояния в реестре: SpO2, Nasal Alar Collapse, Bilateral, Oxygen, Measurement. 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 →

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Официальное название

Philips FAST picoSAT Convenience Sampling for Clinical Performance in Neonate, Infant, and Pediatric Patients

Обзор

The main goal of this study is to look at the performance of the neonatal, infant, and pediatric Philips SpO2 sensors with the Philips FAST Pulse Oximetry technology. Oxygen saturation measurements (SpO2) will be obtained via pulse oximetry and invasive arterial oxygen measurements (SaO2) will be obtained via arterial blood samples as part of your clinical care and assessed by co-oximetry. The study will aim to enroll a diverse population to help us understand the impact of skin pigmentation.

Подробное описание

This is a prospective, multi-center, multi-phase, unblinded, non-randomized. self-controlled, observational study. All data analyses specified below will be calculated and summarized by each of SpO2 sensors under test. Demographics and baseline characteristics, including sex assigned at birth, age, ethnicity, race, baseline height, baseline weight, BMI, skin pigmentation and sensor application site measurements will be summarized with descriptive statistics using the analysis set.

Вмешательства

  • Устройство SaO2 Sampling
    CO-Oximetry analysis of arterial blood samples

Первичные конечные точки

  • To observed accuracy expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth. [Срок оценки: through study completion, an average of 8 months]
Вторичные конечные точки (2)
  • Secondary Endpoint -Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology. [Срок оценки: through study completion, an average of 8 months]
  • Secondary Endpoint- Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 ≥92%) is identified among patients within the broad categories of light, medium, and dark pigmentation. [Срок оценки: through study completion, an average of 8 months]

Критерии участия

Критерии включения

  • Subject aged 18 years or older or parent/legal guardian of subject aged less than 18 years, willing and able to understand and provide written informed consent/assent.
  • Weight and/or age within intended use of at least one SpO2 sensor under test at time of enrollment.
  • Willing and able to wear study devices in addition to SoC devices and during SoC procedures.
  • In-patient within a neonatal or pediatric intensive care unit (e.g. NICU, PICU, PCICU).
  • Has arterial access and ability to have arterial blood samples drawn as part of their SoC and analyzed by CO-Oximetry.

Критерии исключения

  • Known pregnancy or lactating females (self-reported)
  • Injury, wounds, physical malformation, hyperkeratosis, or compromised/non-intact skin at sensor application site (i.e. fingers, toes, hands, feet, ears, nasal ala). Note: Certain malformations may be allowed if determined it would not affect application of sensor with the pulse oximetry system.
  • Self-reported severe contact allergies to standard adhesives or other materials found in pulse oximetry sensors. Note: Subject may be considered eligible if subject can wear non-adhesive sensor.
  • Unwillingness or inability to remove nail polish or artificial nails from sensor application site.
  • Nail fungus on sensor application site.
  • Wearing and unable to remove jewelry from sensor application site.
  • Dye injection within 48 hours of enrollment.
  • Known dysfunctional hemoglobin levels (COHb >3%, MetHb >2%, and ctHb <10g/dl)
  • Undergoing phototherapy for neonatal hyperbilirubinemia during arterial blood sampling

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 5 центров
  • Phoenix Children's — Phoenix
  • University of Nebraska Medical Center — Omaha
  • Duke University Medical Center — Durham
  • Medical University of South Carolina — Charleston
  • Baylor College of Medicine — Houston

Идентификаторы

NCT: NCT06372106 · MA_PM_Mountain_2022_11496

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗