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Набор скоро начнётся NCT07234279

Nellcor™ Investigational Device Sitting-Walking Study

— Наблюдательное Oxygen Saturation

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Oxygen Saturation. Базовые параметры: 18 лет — 75 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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Официальное название

Feasibility of the Investigational Nellcor™ Investigational Device During Non-Motion and Walking Motion Conditions in Adult Volunteers

Обзор

To examine pulse rate and blood oxygen saturation accuracy of the Nellcor™ Investigational Device during non-motion and walking motion conditions in a diverse patient population through non-invasive means

Первичные конечные точки

  • Accuracy of the investigational device SpO2 as compared to the reference device SpO2 [Срок оценки: From enrollment to study exit, 1.5 hours]
  • Accuracy of the investigational device pulse rate as compared to the reference device pulse rate. [Срок оценки: From enrollment to study exit, 1.5 hours]
Вторичные конечные точки (1)
  • Percentage of the time under evaluation that the NellcorTM Investigational Device provides a SpO2 and PR reading [Срок оценки: From enrollment to study exit, 1.5 hours]

Критерии участия

Критерии включения

  • Male or female participants ≥18 years of age, and <75 years of age.
  • Participant is able to participate for the duration of the study
  • Participant is willing to sign an informed consent form (ICF)
  • Participant weighs > 40kg
  • Participants must be a non-smoker or not have smoked within 36 hours prior to the study

Критерии исключения

  • Participant self-reported prior injury or trauma to fingers or hands, which in the opinion of the investigator, may change blood flow or vascular supply and affect the ability to test sensors
  • Physiologic abnormalities that prevent proper application of pulse oximetry sensor
  • Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
  • Individuals of childbearing potential who are self-reported as pregnant, or who are self-reported as trying to get pregnant
  • Morbid obesity (defined as BMI > 39.5)
  • Weight > 136 kg
  • Participants who self-report problems of unsteadiness or imbalance issues and/or who are unable to walk on a treadmill without holding onto the handrails
  • Participant self-reported known heart or cardiovascular conditions such as:
  • Uncontrolled hypertension (Systolic pressure ≥ 140mmHg or Diastolic pressure > 90mmHg on 3 consecutive readings day of screening)
  • Heart arrhythmias other than sinus arrhythmia (Self-reported and/or as identified on ECG day of screening).
  • History of heart attack, blocked artery, history of myocardial ischemia, angina, myocardial infarction, congestive heart failure, cardiomyopathy, stroke, transient ischemic attack, or carotid artery disease
  • Participants with self-reported clotting disorders, such as:
  • History of bleeding disorders or personal history of prolonged bleeding from injury
  • History of blood clots
  • Hemophilia
  • Current use of prescription blood thinner
  • Participants with other self-reported, known health conditions, such as:
  • Diabetes
  • Thyroid disease
  • Kidney disease / chronic renal impairment
  • History of seizures (except childhood febrile seizures), epilepsy, or unexplained syncope
  • Recent history of frequent migraine headaches, as determined medically relevant by the PI
  • History of head injury, as determined medically relevant by the PI
  • Cancer / chemotherapy
  • Sickle cell disease
  • History of hospital admission or a surgical procedure in the 60 days prior to study enrollment (self-reported)
  • Participants with any contraindications to protocol specific repositioning techniques
  • Unwillingness or inability to remove colored nail polish from test digit(s)
  • Participants who have self-reported health conditions beyond what is captured in the prior exclusion criteria, which in the opinion of the Investigator and/or Clinical Staff would classify the participant as medically unsuitable

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07234279 · MDT25003NPDSWF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗