Clinical trial Recruiting at 1 site Observational Ages 18 and up

Assessing sarcopenia and nutrition in patients with tracheostomy during rehabilitation

Official title: 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.

Run by Fondazione Don Carlo Gnocchi ETS · NCT04791540 · Data updated 2026-11-12

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.

More Sarcopenia trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorFondazione Don Carlo Gnocchi ETS
Academic / other
Locations1 site (Florence, Italy)
StatusRecruiting
StartedJune 9, 2021
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedAugust 28, 2025
Trial IDNCT04791540 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients with a tracheostomy who are admitted to a respiratory rehabilitation unit.

Probably not a fit

Patients who are pregnant, refuse participation, or have a pacemaker/implantable cardioverter will 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 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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Fondazione Don Carlo Gnocchi
    Florence, Italy, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.