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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from admission in muscle mass at decannulation time
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent from patients or legal guardians for patients unfit to plead
- •Presence of tracheostomy at admission
排除标准
- •Pregnancy
- •Pace maker/implantable cardioverter
- •No legal guardians for patients unfit to plead
研究组 & 干预措施
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
干预措施: Bioelectrical Impedance Analysis (BIA) (Diagnostic Test)
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
干预措施: handgrip strenght (Diagnostic Test)
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
干预措施: MUST (Diagnostic Test)
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
干预措施: GLIM (Diagnostic Test)
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
干预措施: Gut microbiota (Biological)
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
干预措施: Blood Sample (Biological)
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
干预措施: Anthropometric measures (Other)
结局指标
主要结局
Change from admission in muscle mass at decannulation time
时间窗: 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
时间窗: 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
次要结局
- 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)