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.
Overview
- Phase
- N/A
- Intervention
- Bioelectrical Impedance Analysis (BIA)
- Conditions
- Sarcopenia
- Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change from admission in muscle mass at decannulation time
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent from patients or legal guardians for patients unfit to plead
- •Presence of tracheostomy at admission
Exclusion Criteria
- •Pregnancy
- •Pace maker/implantable cardioverter
- •No legal guardians for patients unfit to plead
Arms & Interventions
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Intervention: Bioelectrical Impedance Analysis (BIA)
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Intervention: handgrip strenght
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Intervention: MUST
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Intervention: GLIM
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Intervention: Gut microbiota
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Intervention: Blood Sample
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Intervention: Anthropometric measures
Outcomes
Primary Outcomes
Change from admission in muscle mass at decannulation time
Time Frame: Respiratory Rehabilitation Unit admission (T0) and decannulation time (T1), an average of 10 days
Measurement of muscle mass with Bioelectrical Impedance Analysis (BIA).
Change from admission in hangrip strenght at decannulation time
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Measurement of handgrip strenght with a handheld dynamometer. Male cut-off: \<27 Kg Female cut-off: \<16 Kg
Secondary Outcomes
- Creatinine(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Albumin(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Vitamin (25OH) D(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Selenium(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Growth Hormone (GH)(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Tumor Necrosis Factor-α (TNF-α)(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Leptin(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Uric Acid(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Magnesium(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Change from admission in Malnutrition Universal Screening Tool (MUST) score at decannulation time(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Change from admission in nutritional status at decannulation time(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Creatine Poshokinase(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Pro-inflammatory cytokine interleukin IL-6(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Insuline-like Growth Factor-1 (IGF-1)(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Dehydroepiandrosterone (DHEA)(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Testosterone(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Change from admission in Body Mass Index (BMI) score at decannulation time(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Change from admission in Gut Microbiota (GM) composition at decannulation time(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Protein C reactive (PCR)(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Lymphocyte count(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)
- Total serum protein(Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days)