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Набор по приглашению NCT06669494

Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired Weakness

— Наблюдательное Cohort Studies ICU Acquired Weakness (ICUAW) 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Cohort Studies, ICU Acquired Weakness (ICUAW), Critical Illness. 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
South Korea
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

Analysis of Data and Development of Physical Function Assessment Indicators for Early Diagnosis and Monitoring Factors of Acquired Weakness in the Intensive Care Unit

Обзор

Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired weakness

Подробное описание

ICU-acquired weakness (ICU-AW) is a prevalent complication, occurring in more than 50% of ICU patients, and has severe long-term effects on patient outcomes. This condition not only prolongs the duration of hospital stay but also persists long after discharge, continuously impacting patients' health and quality of life. Therefore, monitoring, prevention, and rehabilitation of ICU-AW should not be limited to the ICU period but should continue after transfer to general wards and after discharge. This study aims to provide foundational data for developing a platform capable of continuously monitoring and delivering rehabilitation therapy for ICU-AW from ICU admission through the post-discharge period.

Recent meta-analyses have shown that providing rehabilitation for ICU patients improves physical function at discharge, reduces ICU stay by 0.8 days, and shortens total hospital stay by 1.75 days. Additionally, it increases the distance patients can walk unassisted at discharge, the number of patients capable of standing, the duration of ventilator-free days, and the percentage of patients discharged home. Understanding the recovery process of ICU-AW as a continuum from ICU to post-discharge is essential, and the necessity of continuous rehabilitation throughout this process is evident. However, the challenge lies in implementing this in real-world practice.

This study seeks to provide foundational data for developing personalized educational programs applicable to remote digital therapeutics in the future.

Первичные конечные точки

  • MRC sum [Срок оценки: Within 72 hours of ICU admission]
  • Grip strength [Срок оценки: Within 72 hours of ICU admission]
  • FSS-ICU [Срок оценки: Within 72 hours of ICU admission]
  • JH-highest mobility scale [Срок оценки: Within 72 hours of ICU admission]
  • Body composition [Срок оценки: Within 72 hours of ICU admission]
  • US ( muscle thickness) [Срок оценки: Within 72 hours of ICU admission]
  • Fitbit charge 5 [Срок оценки: During ICU status]
  • Nerve conduction study [Срок оценки: Within 72 hours of ICU admission]
  • Clinical Characteristics [Срок оценки: Within 72 hours of ICU admission]
Вторичные конечные точки (7)
  • MRC sum [Срок оценки: Within 24 hours of ICU discharge]
  • Grip strength [Срок оценки: Within 24 hours of ICU admission]
  • FSS-ICU [Срок оценки: Within 24 hours of ICU discharge]
  • JH-highest mobility scale [Срок оценки: Within 24 hours of ICU discharge]
  • Fitbit charge 5 [Срок оценки: Within 24 hours of ICU discharge]
  • US -muscle thickness (T2) [Срок оценки: Within 24 hours of ICU discharge]
  • Body composition(T2) [Срок оценки: Within 24 hours of ICU discharge]

Критерии участия

Критерии включения

  • Patients admitted to the ICU who are 19 years of age
  • Patients who did consent of the study

Критерии исключения

  • Patients with a history of peripheral nerve injury
  • Patients with a history of major surgery within the past 12 weeks or those expected to undergo major surgery during the trial period
  • Patients with a history of central nervous system disorders (e.g., stroke, spinal cord injury)
  • Patients with cognitive impairment that may interfere with the conduct of the study
  • Patients with Do Not Resuscitate (DNR) orders, brain lesions, Clinical Frailty Score (CFS) exceeding 4, or those who have undergone cardiopulmonary resuscitation
  • Patients confirmed to have metastatic cancer

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 1 центр
  • Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT06669494 · 2024-06-107

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗