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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093125 on ClinicalTrials.gov