Rehabilitation Practices in Critically Ill Patients Receiving Invasive Mechanical Ventilation in the Intensive Care Unit.
NCT07093125 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2400
Last updated 2026-05-04
Summary
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.
Conditions
- Mechanical Ventilation
- Pulmonary Rehabilitation
- Intensive Care Units (ICUs)
- Quality of Life (QOL)
- Outcome Assessment
- Extubation Failure
- Mortality
- Critical Care
Sponsors & Collaborators
-
Amsterdam UMC, location VUmc
collaborator OTHER -
Universita degli Studi di Genova
lead OTHER
Principal Investigators
-
Denise Battaglini, MD, PhD · Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy
-
Marcus J Schultz, MD, PhD · Amsterdam University Medical Centers, Amsterdam, The Netherlands
-
Rik Gosselink, PT, PhD · University of Leuven, Leuven, Belgium
-
Sabrine N.T. Hemmes, MD, PhD · Amsterdam University Medical Centers, Amsterdam, The Netherlands
-
Carol L. Hodgson, PhD FACP FAHMS BAppSc(PT) MPhi · Alfred Hospital, Melbourne, VIC, Australia
-
Ricardo Kenji Nawa, MD, PhD · Hospital Israelita Albert Einstein, São Paulo, SP, Brazil
-
Irene Schiavetti, PhD · University of Genoa, Italy
-
Ary Serpa Neto, MD, PhD · Monash University, Melbourne, VIC, Australia
-
Gentle S. Shrestha, MD, PhD · University Teaching Hospital, Kathmandu, Bagmati, Nepal
Eligibility
- Min Age
- 16 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2028-10-01
- Completion
- 2029-10-01
Countries
- Italy
Study Locations
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