Rehabilitation for patients with chronic critical illness
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
Fondazione Don Carlo Gnocchi Onlus · NCT06453421
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 |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus (other) |
| Locations | 1 site (Florence) |
| Trial ID | NCT06453421 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is observational, similar studies have shown promise in understanding and improving rehabilitation outcomes for critically ill patients.
Eligibility criteria
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 this trial is running
Florence
- 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
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: Rehabilitation, Chronic Critical Illness