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| Name | Class |
|---|---|
| University of Florence | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with trachestomy | Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| handgrip strenght | Diagnostic Test | Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from admission in muscle mass at decannulation time | Measurement of muscle mass with Bioelectrical Impedance Analysis (BIA). | 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 | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent tracheostomy before admission, attending a rehabilitation program
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiara F Gheri, MD | Contact | 00390557393612 | cgheri@dongnocchi.it |
| Name | Affiliation | Role |
|---|---|---|
| Chiara F Gheri, MD | Fondazione Don Carlo Gnocchi ETS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Don Carlo Gnocchi | Recruiting | Florence | Italy | 50143 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30920778 | Background | Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats AJS, Crivelli AN, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee, GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. J Cachexia Sarcopenia Muscle. 2019 Feb;10(1):207-217. doi: 10.1002/jcsm.12383. | |
| 31081853 |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069196 | Gastrointestinal Microbiome |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D064307 | Microbiota |
| D008827 | Microbiological Phenomena |
| D058448 | Biota |
| D044822 | Biodiversity |
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| Bioelectrical Impedance Analysis (BIA) | Diagnostic Test | Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1) |
|
| MUST | Diagnostic Test | Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1) |
|
| GLIM | Diagnostic Test | Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1) |
|
| Gut microbiota | Biological | A fecal sample obtained at admission (T0) and at decannulation time (T1) |
|
| Blood Sample | Biological | A Blood sample obtained at admission (T0) and at decannulation time (T1) |
|
| Anthropometric measures | Other | Measurement of weight and height (assessed only at admission) to calculate the Body Mass Index (BMI), at admission (T0) and at decannulation time (T1) |
|
| 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 | 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. | 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 | 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 | 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 | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days |
| Creatinine | Change from admission in creatinine at decannulation time | 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 | 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 | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days |
| Albumin | Change from admission in albumin at decannulation time | 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 | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days |
| Selenium | Change from admission in selenium at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days |
| Leptin | Change from admission in leptin at decannulation time | 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 | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days |
| Magnesium | Change from admission in magnesium at decannulation time | 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 | 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 | 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 | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days |
| Testosterone | Change from admission in testosterone at decannulation time | 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 | 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 | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days |
| Background |
| Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available. |
| 15556267 | Background | Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Manuel Gomez J, Lilienthal Heitmann B, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, M W J Schols A, Pichard C; ESPEN. Bioelectrical impedance analysis-part II: utilization in clinical practice. Clin Nutr. 2004 Dec;23(6):1430-53. doi: 10.1016/j.clnu.2004.09.012. |
| 29202866 | Background | Kutsukutsa J, Mashamba-Thompson TP, Saman Y. Tracheostomy decannulation methods and procedures in adults: a systematic scoping review protocol. Syst Rev. 2017 Dec 4;6(1):239. doi: 10.1186/s13643-017-0634-0. |
| 31319564 | Background | Ticinesi A, Nouvenne A, Cerundolo N, Catania P, Prati B, Tana C, Meschi T. Gut Microbiota, Muscle Mass and Function in Aging: A Focus on Physical Frailty and Sarcopenia. Nutrients. 2019 Jul 17;11(7):1633. doi: 10.3390/nu11071633. |
| 29789798 | Background | Toptas M, Yalcin M, Akkoc I, Demir E, Metin C, Savas Y, Kalyoncuoglu M, Can MM. The Relation between Sarcopenia and Mortality in Patients at Intensive Care Unit. Biomed Res Int. 2018 Feb 12;2018:5263208. doi: 10.1155/2018/5263208. eCollection 2018. |
| 30169116 | Background | Prado CM, Purcell SA, Alish C, Pereira SL, Deutz NE, Heyland DK, Goodpaster BH, Tappenden KA, Heymsfield SB. Implications of low muscle mass across the continuum of care: a narrative review. Ann Med. 2018 Dec;50(8):675-693. doi: 10.1080/07853890.2018.1511918. Epub 2018 Sep 12. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D017753 |
| Ecosystem |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |