ICU rehabilitation for adults on invasive mechanical ventilation
An Observational Study on Rehabilitation Practices in the ICU for Critically Ill Patients Undergoing Invasive Mechanical Ventilation - Report (REPOrt)
Universita degli Studi di Genova · NCT07093125
This project will look at rehabilitation approaches used in ICUs worldwide to see if they relate to outcomes for adults who have been on invasive mechanical ventilation for at least 48 hours.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2400 (estimated) |
| Ages | 16 Years to 100 Years |
| Sex | All |
| Sponsor | Universita degli Studi di Genova (other) |
| Locations | 1 site (Genova, Italy) |
| Trial ID | NCT07093125 on ClinicalTrials.gov |
What this trial studies
This international, multicenter observational project collects detailed information on rehabilitation practices for adults receiving invasive mechanical ventilation in participating ICUs. It is organized into a mandatory BASIC module that captures core data on interventions and outcomes, with optional EXTENDED modules for more detailed therapy characteristics and longer follow-up depending on local resources. The study links rehabilitation modalities (mobilization, respiratory physiotherapy, occupational therapy, dysphagia care, and cognitive support) to ICU outcomes including ICU and hospital mortality, length of stay, duration of ventilation, extubation failure, and functional status 28 days after ICU discharge. Centers across different geographic and economic regions will be compared to identify practice variation and potential disparities.
Who should consider this trial
Good fit: Adults (typically aged 16 or older depending on local regulations) admitted to a participating ICU who have received invasive mechanical ventilation for at least 48 hours and have provided appropriate consent are eligible.
Not a fit: Patients admitted for withdrawal of life-sustaining therapy, those ventilated for less than 48 hours, or patients treated outside participating centers are unlikely to benefit from this project's findings.
Why it matters
Potential benefit: If successful, the results could identify rehabilitation practices associated with better survival, shorter ICU stays, and improved functional recovery, guiding ICU teams to prioritize effective therapies.
How similar studies have performed: Previous randomized and observational studies generally support benefits of early mobilization and pulmonary rehabilitation, but findings vary and comprehensive international practice-level comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: • Patients admitted for withdrawn of life sustain therapy
Where this trial is running
Genova, Italy
- IRCCS Ospedale Policlinico San Martino — Genova, Italy, Italy (RECRUITING)
Study contacts
- Principal investigator: Denise Battaglini, MD, PhD — Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy
- Study coordinator: Denise Battaglini, MD, PhD
- Email: denise.battaglini@unige.it
- Phone: ＋39 010 5554970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mechanical Ventilation, Pulmonary Rehabilitation, Intensive Care Units, Quality of Life, Outcome Assessment, Extubation Failure, Mortality, Critical Care