Dosage of Early Rehabilitation of ICU Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Critical Care, Intensive Care, Critical Illness, Physiotherapy, Early Ambulation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Rehabilitation of Intensive Care Unit Patients - a Multinational Prospective Observational Study on Dosage and Outcome
Overview
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.
Detailed description
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.
Primary outcome measures
- Physical function at ICU discharge [Time frame: ICU discharge (up to Day 28)]
Secondary outcome measures (10)
- Highest level of mobility at ICU discharge and 90 days [Time frame: ICU discharge (up to Day 28) and Day 90]
- Physical function at 90 days [Time frame: Day 90]
- Frailty/ Functional status at ICU discharge and 90 days [Time frame: ICU discharge (up to Day 28) and Day 90]
- ICU LOS [Time frame: ICU admission until ICU discharge (up to Day 28)]
- Hospital LOS [Time frame: ICU admission until hospital discharge]
- ICU mortality [Time frame: ICU admission until ICU discharge (up to Day 28)]
- Hospital mortality [Time frame: ICU admission until hospital discharge]
- 90-day mortality [Time frame: Day 90]
- Disability at 90 days [Time frame: Day 90]
- Activities of Daily Living (ADLs) at ICU discharge and 90 days [Time frame: ICU discharge (up to Day 28) and Day 90]
Eligibility criteria
Inclusion criteria
- Adults (≥ 18 years old) within 48 hours of ICU admission
- Expected to stay > 24 hours in the ICU
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Medical University of Vienna — Vienna
Identifiers
NCT: NCT06960642 · ERUPT