Assessing sarcopenia and nutrition in patients with tracheostomy during rehabilitation
Observational Pilot Study in Patients Who Underwent Tracheostomy: Sarcopenia Assessment by Handgrip Strenght and BIA. Association to Malnutrion Risk, Nutritional Status, Gut Microbioma and Decannulation Time.
This study is trying to see how muscle strength and nutrition affect the time it takes for patients with a tracheostomy to breathe without the tube during their rehabilitation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 1 site (Florence, Italy) |
| Trial ID | NCT04791540 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between sarcopenia, measured through handgrip strength and bioelectrical impedance analysis (BIA), and the time taken for decannulation in patients undergoing respiratory rehabilitation after tracheostomy. Additionally, it will explore the impact of malnutrition risk and nutritional status on decannulation time, as well as the composition of gut microbiota. The study will involve collecting data from patients in a specialized rehabilitation unit to identify potential associations that could inform future interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a tracheostomy who are admitted to a respiratory rehabilitation unit.
Not a fit: Patients who are pregnant, refuse participation, or have a pacemaker/implantable cardioverter will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for patients with tracheostomy, enhancing their recovery and quality of life.
How similar studies have performed: While this study explores associations that have not been extensively tested in this specific context, similar studies have shown the importance of nutritional status in rehabilitation outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent from patients or legal guardians for patients unfit to plead * Presence of tracheostomy at admission Exclusion Criteria: * Refusal * Pregnancy * Pace maker/implantable cardioverter * No legal guardians for patients unfit to plead
Where this trial is running
Florence, Italy
- Fondazione Don Carlo Gnocchi — Florence, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Chiara F Gheri, MD — Fondazione Don Carlo Gnocchi Onlus
- Study coordinator: Chiara F Gheri, MD
- Email: cgheri@dongnocchi.it
- Phone: 00390557393612
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.