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Идёт набор NCT06960642

Dosage of Early Rehabilitation of ICU Patients

Наблюдательное Critical Care, Intensive Care Critical Illness Physiotherapy Early Ambulation

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: Critical Care, Intensive Care, Critical Illness, Physiotherapy, Early Ambulation. 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
Австрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Early Rehabilitation of Intensive Care Unit Patients - a Multinational Prospective Observational Study on Dosage and Outcome

Обзор

Rehabilitation already begins in the intensive care unit (ICU) to maintain or restore the functional capacity of ICU patients and to counteract the long-term effects of intensive care treatment. Mobilisation is an important component. The aim of this multinational observational study is to record and evaluate the different mobilisation practices for ICU patients worldwide. The investigators want to find out which forms of mobilisation in intensive care patients achieve the best results in terms of physical function, functional status and quality of life. The goal is to recruit over 6,000 patients internationally. No interventions will be carried out, only routine clinical data will be documented and standardised and already established physical tests and questionnaires will be used.

Подробное описание

Intensive care treatment can have long-term effects on patients. Around 40% of intensive care unit (ICU) patients develop an Intensive Care Unit Acquired Weakness (ICUAW), which leads to functional limitations and an impairment of independence, participation in everyday life, quality of life and ability to work. Recent studies have shown that early mobilisation has a positive effect on the course of the disease, including improved physical function and independence, shorter ventilation times, and shorter ICU and hospital stays. However, there is currently no standardised approach to mobilisation and the dosage required to achieve the best health outcomes in ICU patients is unknown. There is also a lack of data on patients who were functionally dependent before hospital admission and on patients who were not on invasive mechanical ventilation.

The main objectives of the observational study are:

1. Assessment of the variety of different mobilisation practices worldwide. 2. The analysis of the association of mobilisation dosage on patient outcomes. 3. The evaluation of the association of the prehospital functional status or invasive mechanical ventilation on patient outcomes.

The investigators aim to recruit over 6,000 patients internationally from a minimum of 200 intensive care units. The total duration of the study is 21 months, with participation per patients being 90 days. Routine clinical data and mobilisation data from ICU will be documented, and standardised functional tests and questionnaires will be conducted.

Первичные конечные точки

  • Physical function at ICU discharge [Срок оценки: ICU discharge (up to Day 28)]
Вторичные конечные точки (10)
  • Highest level of mobility at ICU discharge and 90 days [Срок оценки: ICU discharge (up to Day 28) and Day 90]
  • Physical function at 90 days [Срок оценки: Day 90]
  • Frailty/ Functional status at ICU discharge and 90 days [Срок оценки: ICU discharge (up to Day 28) and Day 90]
  • ICU LOS [Срок оценки: ICU admission until ICU discharge (up to Day 28)]
  • Hospital LOS [Срок оценки: ICU admission until hospital discharge]
  • ICU mortality [Срок оценки: ICU admission until ICU discharge (up to Day 28)]
  • Hospital mortality [Срок оценки: ICU admission until hospital discharge]
  • 90-day mortality [Срок оценки: Day 90]
  • Disability at 90 days [Срок оценки: Day 90]
  • Activities of Daily Living (ADLs) at ICU discharge and 90 days [Срок оценки: ICU discharge (up to Day 28) and Day 90]

Критерии участия

Критерии включения

  • Adults (≥ 18 years old) within 48 hours of ICU admission
  • Expected to stay > 24 hours in the ICU

Критерии исключения

  • Patients who receive end-of-life care at the time of screening
  • Patients whose treatment plans are still under discussion and/or not all team members are committed to full active treatment
  • Patients whose functional status is unlikely to be obtainable
  • Patients with language barriers

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Австрия · 1 центр
  • Medical University of Vienna — Vienna

Идентификаторы

NCT: NCT06960642 · ERUPT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗