Sarcopenia and Nutritional Status in a Rehabilitation Setting
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.
Fondazione Don Carlo Gnocchi Onlus
30 participants
Jun 9, 2021
OBSERVATIONAL
Conditions
Summary
In this pilot observational study the primary outcome is to assess, in a Respiratory Rehabilitation Unit, if there is an association between sarcopenia, assessed by handgrip strenght and BIA, and a delayed decannulation time in patients who underwent tracheostomy. Secondary outcomes are to assess if there is an association between an increased malnutrition risk (assessed by MUST), a poor nutritional status (assessed by GLIM criteria) and a delayed decannulation time and the gut microbiota composition.
Eligibility
Inclusion Criteria2
- Signed informed consent from patients or legal guardians for patients unfit to plead
- Presence of tracheostomy at admission
Exclusion Criteria4
- Refusal
- Pregnancy
- Pace maker/implantable cardioverter
- No legal guardians for patients unfit to plead
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)
Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)
Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)
Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)
A fecal sample obtained at admission (T0) and at decannulation time (T1)
A Blood sample obtained at admission (T0) and at decannulation time (T1)
Measurement of weight and height (assessed only at admission) to calculate the Body Mass Index (BMI), at admission (T0) and at decannulation time (T1)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04791540