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
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Research Publications
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
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
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
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.
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.