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Набор скоро начнётся NCT06692374

Automated Cardiac Arrest Detection and Alerting in Daily Life

— Наблюдательное Cardiac Arrest (CA) Sudden Death, Cardiac

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: Cardiac Arrest (CA), Sudden Death, Cardiac. 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
Нидерланды
Следующий шаг
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Официальное название

Smartwatch-based Automated Cardiac Arrest Detection and Activation of the Emergency Medical Chain: Validation in a Home Setting

Обзор

Surviving a cardiac arrest that happens outside the hospital depends on quickly recognizing the event and immediately starting CPR. Survival rates have improved when cardiac arrest is witnessed, but when it isn't, help often arrives too late. Wearable biosensors, like special wristbands, could detect cardiac arrest automatically and alert emergency responders, providing faster help. In the already finished DETECT-1 study, the investigators developed a system that uses wrist-worn sensors to identify cardiac arrest. The goal of the current study is to test how well this system works in people who have an implantable cardioverter defibrillator (ICD). An ICD is a device that monitors and treats dangerous heart rhythms. Study participants will wear a medical wristband with sensors that monitor the heartrate and movement during their daily activities to see if the system accurately detects cardiac arrest.

Подробное описание

Survival from out-of-hospital cardiac arrest (OHCA) depends on fast recognition of cardiac arrest and immediate initiation of cardiopulmonary resuscitation (CPR). While survival chances for witnessed OHCA have increased, unwitnessed cases still often receive help too late. Wearable biosensor technology with the functionality of automated cardiac arrest detection and activation of the emergency medical chain would offer a potential solution to provide early help. In the recently published DETECT-1 study, an algorithm for automated cardiac arrest detection using wrist-derived photoplethysmography (PPG) was recently developed.

The current study is a prospective multicenter observational cohort study to validate the sensitivity of the developed cardiac arrest detection algorithm in patients with an implantable cardioverter defibrillator (ICD) during daily life. The study population includes patients with an ICD. Study participants will wear a medical wristband with PPG and accelerometer sensors during daily life.

Первичные конечные точки

  • Sensitivity for cardiac arrest detection [Срок оценки: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)]
Вторичные конечные точки (2)
  • Positive predictive value for cardiac arrest detection [Срок оценки: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)]
  • False positive alarm rate [Срок оценки: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)]

Критерии участия

Критерии включения

  • Patients with an implantable cardioverter defibrillator (ICD)
  • Age 18 years or older
  • Fitting the wristband
  • In possession of a smartphone that is compatible with the wristband

Критерии исключения

  • Known hemodynamically relevant bilateral subclavian artery stenosis
  • Medical issues that interfere with wearing of the wristband (e.g. skin disorders)
  • Insufficient skills to operate with the device/app

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • RadboudUMC — Nijmegen

Публикации

  • Edgar R, Scholte NTB, Ebrahimkheil K, Brouwer MA, Beukema RJ, Mafi-Rad M, Vernooy K, Yap SC, Ronner E, van Mieghem N, Boersma E, Stas PC, van Royen N, Bonnes JL. Automated cardiac arrest detection using a photoplethysmography wristband: algorithm development and validation in patients with induced circulatory arrest in the DETECT-1 study. Lancet Digit Health. 2024 Mar;6(3):e201-e210. doi: 10.1016/ PMID 38395540

Идентификаторы

NCT: NCT06692374 · 116424

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗