Actively Recruiting

Age: 16Years - 100Years
All Genders
ID07093125

An Observational Study on Rehabilitation Practices in the ICU for Critically Ill Patients Undergoing Invasive Mechanical Ventilation - Report (REPOrt)

Led by Universita degli Studi di Genova · Updated on 2026-05-04

2400

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

Universita degli Studi di Genova

Lead Sponsor

A

Amsterdam UMC, location VUmc

Collaborating Sponsor

AI-Summary

What this Trial Is About

This international, multicenter observational study focuses on critically ill adult patients receiving invasive mechanical ventilation in Intensive Care Units (ICUs) worldwide. Researchers aim to describe and compare rehabilitation practices across different geographic and economic regions. The study seeks to understand how rehabilitation interventions relate to key ICU outcomes such as mortality, length of stay, ventilation duration, extubation failures, and long-term quality of life and functional recovery 28 days after ICU discharge. The study consists of three modules: the BASIC module (mandatory), which collects fundamental data on rehabilitation practices and patient outcomes; the EXTENDED module (optional), which gathers detailed information about rehabilitation types, timing, duration, safety, and delivery; and the EXTENDED FOLLOW-UP module (optional), which assesses quality of life and functional performance 28 days post-ICU discharge. Rehabilitation interventions studied include passive and active exercises, respiratory physiotherapy, dysphagia training, occupational therapy, and cognitive support. Participants are admitted ICU patients aged 16 or older who have received invasive ventilation for at least 48 hours. Data collection occurs at ICU admission, multiple ICU stay time points (days 0, 3, 7, 14, and discharge), and at a 28-day follow-up post-ICU discharge. Assessments include muscle strength, mobility level, intervention duration, safety monitoring, and functional and quality of life evaluations. The study uses electronic data capture with thorough data validation, monitoring, and auditing to ensure data quality and integrity. Enrollment spans 120 days per center with an expected total of 1,200 to 2,400 patients worldwide.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 16Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients admitted to a participating ICU
  • Adult patients aged 16 years or older, depending on local regulations
  • Patients who have received invasive ventilation for at least 48 hours
  • Patients who have provided written informed consent or whose next of kin has provided consent if required by local laws
Not Eligible

You will not qualify if you...

  • Patients admitted for withdrawal of life-sustaining therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - Up to 120 days

Participants are screened for eligibility to participate in the trial.

1 to 2 visits depending on local consent procedures

Monitoring

Duration - From ICU admission until ICU discharge (up to 28 days)

Participants are observed during their ICU stay to collect data on rehabilitation practices, muscle strength, and ICU outcomes.

Visits at ICU admission (Day 0), Days 3, 7, 14, and ICU discharge

Long-term Monitoring

Duration - From ICU discharge to 28 days post-ICU discharge

Participants are followed up after ICU discharge to evaluate quality of life, functional performance, and mortality.

1 follow-up visit at 28 days post-ICU discharge

Trial Site Locations

Total: 1 location

1

IRCCS Ospedale Policlinico San Martino

Genova, Italy, Italy, 16132

Actively Recruiting

Loading map...

Research Team

D

Denise Battaglini, MD, PhD

M

Marcus J Schultz, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

A Feasibility Trial of Eye Movement Desensitization and Repr...

Post Traumatic Stress Symptoms

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients.

R Gosselink, J Bott, M Johnson...

https://pubmed.ncbi.nlm.nih.gov/18283429

Early Active Mobilization during Mechanical Ventilation in the ICU.

TEAM Study Investigators and the ANZICS Clinical Trials Group, Carol L Hodgson, Michael Bailey...

https://pubmed.ncbi.nlm.nih.gov/36286256

Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial.

William D Schweickert, Mark C Pohlman, Anne S Pohlman...

https://pubmed.ncbi.nlm.nih.gov/19446324