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.
Study Type
OBSERVATIONAL
Enrollment
30
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)
Fondazione Don Carlo Gnocchi
Florence, Italy, Italy
RECRUITINGChange from admission in muscle mass at decannulation time
Measurement of muscle mass with Bioelectrical Impedance Analysis (BIA).
Time frame: Respiratory Rehabilitation Unit admission (T0) and decannulation time (T1), an average of 10 days
Change from admission in hangrip strenght at decannulation time
Measurement of handgrip strenght with a handheld dynamometer. Male cut-off: \<27 Kg Female cut-off: \<16 Kg
Time frame: 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
Measurement of height and weight to get a BMI score (weight/(height\^2). BMI \<18.5 Kg/m\^2: underweight BMI 18.5-24.9 Kg/m\^2: normal range BMI 25.0-29.9 Kg/m\^2: overweight BMI 30.0-34.9 Kg/m\^2 obese class I BMI 35.0-39.9 Kg/m\^2 obese class II BMI \>= 40 Kg/m\^2 obese class III
Time frame: 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
MUST is a screening tool to identify adults who are malnourished, at risk of malnutrition or obese. score 0: low risk score 1: medium risk score 2 or more: high risk
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Change from admission in nutritional status at decannulation time
Global Leadership Initiative on Malnutrition (GLIM) criteria are 5 diagnostic criteria to assess malnutrition that include 3 phenotypic (weight loss, low body mass index and reduced muscle mass) and 2 etiologic (reduced food intake/assimilation, and inflammation/disease burden) criteria. To diagnose malnutrition at least 1 phenotypic criterion and 1 etiologic criterion should be present.
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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)
Time frame: 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
Gut Microbiota (GM) composition
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Protein C reactive (PCR)
Change from admission in Protein C reactive (PCR) at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Lymphocyte count
Change from admission in lymphocyte count at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Creatinine
Change from admission in creatinine at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Creatine Poshokinase
Change from admission in creatine poshokinase at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Total serum protein
Change from admission in total serum protein at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Albumin
Change from admission in albumin at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Vitamin (25OH) D
Change from admission in vitamin (25OH) D at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Selenium
Change from admission in selenium at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Leptin
Change from admission in leptin at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Uric Acid
Change from admission in uric acid at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Magnesium
Change from admission in magnesium at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Growth Hormone (GH)
Change from admission in growth hormone at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Insuline-like Growth Factor-1 (IGF-1)
Change from admission in Insuline-like Growth Factor-1 (IGF-1) at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Dehydroepiandrosterone (DHEA)
Change from admission in dehydroepiandrosterone (DHEA) at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Testosterone
Change from admission in testosterone at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Pro-inflammatory cytokine interleukin IL-6
Change from admission in pro-inflammatory cytokine interleukinIL-6 at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Tumor Necrosis Factor-α (TNF-α)
Change from admission in Tumor Necrosis Factor-α (TNF-α) at decannulation time
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days