About this trial
This international, multicenter, observational study aims to describe rehabilitation practices in Intensive Care Units (ICUs) worldwide.
The primary objective is to provide an overview of current rehabilitation strategies used in ICUs globally.
Secondary objectives include assessing the relationship between rehabilitation and key ICU outcomes such as ICU and hospital mortality, length of stay, duration of invasive ventilation, extubation failures, and long-term outcomes including quality of life and functional performance 28 days post-ICU discharge.
The study will also compare rehabilitation practices across different geographic and economic regions to identify potential disparities. The study is structured into three modules, with participation contingent on local resources and feasibility.
The BASIC Module (mandatory for all centers) gathers fundamental data on rehabilitation practices and their association with patient outcomes.
The EXTENDED Module (optional) collects more detailed information on the type, timing, duration, and safety of rehabilitation interventions, including passive exercises, active mobilization, respiratory therapies, dysphagia training, occupational therapy, and cognitive support.
The EXTENDED FOLLOW-UP Module (optional) evaluates the patient's quality of life and functional recovery 28 days after ICU discharge. By examining global rehabilitation practices and their impact on patient outcomes, this study aims to improve rehabilitation strategies in ICUs, contributing to better patient care, recovery, and long-term health outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted to a participating ICU
Adult patients (aged 16 years or older, depending on local regulations for the definition of "adults")
Patients who have received invasive ventilation for at least 48 hours
Patients who have obtained written informed consent from the patient or next of kin (if local legislation demands so)
Disqualifiers
None
Trial population
The study population will comprise adult patients admitted to Intensive Care Units (ICUs) located in cities and countries participating in the study. Eligible patients will be adult patients requiring invasive mechanical ventilation for at least 48 hours and who can be candidate for rehabilitation during ICU stay. Enrolment will be conducted in accordance with applicable local regulations, including the provision of informed consent by the patient or their legally authorized representative.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Proportion of patients receiving at least one rehabilitation intervention
Rehabilitation is defined as the delivery of at least one documented intervention during ICU stay, including passive mobilization, active mobilization, or respiratory physiotherapy (active or passive), reported as percentage (%).
Secondary outcomes
Proportion of patients receiving each type of rehabilitation intervention
Percentage of patients receiving each predefined type of rehabilitation intervention, including passive mobilization, active mobilization, passive respiratory physiotherapy, active respiratory physiotherapy, occupational therapy, dysphagia management, and cognitive or psychological support. Categories are not mutually exclusive.
Duration of rehabilitation interventions per day (minutes)
Duration in minutes of rehabilitation interventions per day, separated into (1) mobilization and (2) respiratory physiotherapy. Minutes per day (median \[IQR\]).
ICU length of stay
Length of stay in the ICU
ICU mortality
Mortality during ICU stay
Sponsors and contacts
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Universita degli Studi di Genova
Lead sponsor
Amsterdam UMC, location VUmc
Collaborator