Rehabilitation for patients with chronic critical illness
Official title: Pulmonary Rehabilitation in the Chronically Critically Ill Patient: Prospective Study About Clinical Characteristics and the Response to Rehabilitation in This Patient Population and Search for Potential Predictive Factors
Run by Fondazione Don Carlo Gnocchi ETS · NCT06453421 · Data updated 2026-11-12
This study looks at how patients with chronic critical illness respond to respiratory rehabilitation after long-term use of a breathing machine to see if it helps them recover and improve their chances of getting off the machine.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Fondazione Don Carlo Gnocchi ETS Academic / other |
| Locations | 1 site (Florence) |
| Status | Recruiting |
| Started | February 10, 2023 |
| Main results expected | January 31, 2028 |
| Study ends | August 10, 2029 |
| Registry record updated | March 3, 2025 |
| Trial ID | NCT06453421 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who have experienced acute or acute-on-chronic respiratory failure requiring prolonged invasive mechanical ventilation via tracheostomy.
✕Probably not a fit
Patients who are clinically unstable and require transfer to an acute hospital within the first week of hospitalization may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to understand the characteristics and responses of chronically critically ill patients who are referred to respiratory rehabilitation units after requiring prolonged invasive mechanical ventilation via tracheostomy. It will collect data on their clinical and pathophysiological profiles, evaluate their functional recovery, and assess outcomes such as weaning from mechanical ventilation and mortality. The study also seeks to identify prognostic indicators that could help optimize rehabilitation resources for these patients. Conducted at the Don Gnocchi Foundation in Florence, it focuses on improving care for this vulnerable population.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation strategies and improve outcomes for patients with chronic critical illness.
How similar studies have gone: While this approach is observational, similar studies have shown promise in understanding and improving rehabilitation outcomes for critically ill patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \>18 years; * episode of acute or acute-on-chronic respiratory failure with the need for prolonged invasive mechanical ventilation via tracheostomy Exclusion Criteria: condition of clinical instability such as to make it necessary to transfer the patient to acute hospital within the first 7 days of hospitalization.
Where it's running
-
IRCCS Fondazione Don Carlo Gnocchi ONLUS
Florence, Italy Recruiting
Study contacts
- Principal investigator: Elisa Chellini, MD — IRCCS Fondazione Don Carlo Gnocchi ONLUS
- Study coordinator: Francesco Gigliotti, MD
- Email: fgigliotti@dongnocchi.it
- Phone: +390557393913
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.