Rehabilitation Practices in Critically Ill Patients Receiving Invasive Mechanical Ventilation in the Intensive Care Unit.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-100
SponsorUniversita degli Studi di Genova

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,400 Participants
are grouped into 1 trial group
Group A: Adult patients admitted in ICU and on mechanical ventilation for at least 48 hours

Trial outcomes

Primary outcomes

1

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 (%).

Time frame
From ICU admission (Day 0) until ICU discharge (up to Day 365)

Secondary outcomes

1

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.

Time frame
From ICU admission until ICU discharge (up to Day 365)
2

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 \[IQR\]).

Time frame
From ICU admission (Day 0) until ICU discharge (up to day 365)
3

ICU length of stay

Length of stay in the ICU

Time frame
From ICU admission (Day 0) until ICU discharge (up to day 365)
4

ICU mortality

Mortality during ICU stay

Time frame
From ICU admission (Day 0) until ICU discharge (up to day 365)

Other outcomes

Sponsors and contacts

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Universita degli Studi di Genova

Lead sponsor

Amsterdam UMC, location VUmc

Collaborator