NCT07093125 Rehabilitation Practices in Critically Ill Patients Receiving Invasive Mechanical Ventilation in the Intensive Care Unit.
| NCT ID | NCT07093125 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universita degli Studi di Genova |
| Condition | Mechanical Ventilation |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,400 participants in total. It began in 2025-10-01 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Denise Battaglini, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy
Frequently Asked Questions
Who can join the NCT07093125 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 100 Years, studying Mechanical Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07093125 currently recruiting?
Yes, NCT07093125 is actively recruiting participants. Contact the research team at denise.battaglini@unige.it for enrollment information.
Where is the NCT07093125 trial being conducted?
This trial is being conducted at Genova, Italy.
Who is sponsoring the NCT07093125 clinical trial?
NCT07093125 is sponsored by Universita degli Studi di Genova. The principal investigator is Denise Battaglini, MD, PhD at Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy. The trial plans to enroll 2,400 participants.