跳至主要内容
临床试验/NCT04639648
NCT04639648已完成不适用

Nutritional Status Evaluation of Hospitalized Patients With Acute Respiratory Failure and COPD

Fondazione Fatebenefratelli1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Correlation between BMI (Kg/m2) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD

研究概览

简要总结

Malnutrition is a comorbidity oftenly seen in COPD patients who have progressive chronic inflammation and severity. The investigators aimed to determine the impact of nutritional status and nutrition-related factors on prolonged length of stay in hospitalized patients with acute respiratory failure and COPD. Nutritional status has been defined as an individual's health condition as it is influenced by the intake and utilization of nutrients (Todhunter, 1970). Nutritional status can be defined by energy balance, body composition and body function, moreover the chronic inflammation and the physical activity have an important role. In the study is used some tools (anthropometry, Nutritional Risk Screening [NRS 2002], food intake, body composition, Fat-Free Mass Index [FFMI], diaphragm ultrasound for evaluating diaphragmatic mobility, blood tests, hand) to define nutritional status. The investigatos'll analyze prevalance of malnutrition in the sample and the correlation of malnutrition with prolonged length of stay in hospitalized patients with acute respiratory failure and COPD.

详细描述

Introduction:

Chronic obstructive pulmonary disease (COPD) is a lung disease characterized by chronic obstruction of lung airflow that interferes with normal breathing and is not fully reversible. In Italy the disease frequency is growing, our last estimate by National Health Service in the year 2014 shows more than 6 cases on 100 people (6% of the population).

Materials and methods:

  • Sample selection: 40 partecipants were enrolled in the Internal Medicine Department of S. Giovanni Calibita Fatebenefratelli Hospital in Rome
  • Data collection: anamnesis (sex, age, GOLD classification, active pathologies, length of stay in hospital); Nutritional Risk Screening [NRS 2002]; food Intake: as pergentage of ingesta in the last meal; (MMRC) dyspnea scale.
  • Anthropometry parameters: height , body weight, arm circumference, triceps skin fold thickness and Body Mass index was calculated [BMI = weight (Kg) / (stature (m))²]
  • Body Composition: bioimpedance analysis (fat free mass, fat mass, phase angle, fat free mass index [height-normalized index of FFM, which is calculated by dividing FFM (in kg) by height (in m2) ]).
  • Blood tests: albumin (g/dL), transferrin (mg/dL), prealbumin (mg/dL), lymphocytes /mm3, Retinol-binding protein (mg/dL), PCR (mg/L), NLR (neutrophil-lymphocyte ratio)
  • Functional examinations: handgrip
  • Diaphragm ultrasound performed during quiet respiration. The right diaphragm is analyzed through the liver window. The transducer is placed in the anterior subcostal region between the mid clavicular and anterior axillary lines. The ultrasound beam should reach the posterior part of the diaphragm. In the B mode view, the diaphragm is identified as an echogenic line between the interface of the lung and liver or spleen. Then, M mode is performed to record diaphragmatic excursion during respiration.

Statistics Demographic and clinical features were summarized with the descriptive statistic (mean, standard deviation, median, interquartile range) for continuous variables and with absolute frequencies and percentage for categorical variables. We used Chi-Square Tests or Fisher's Exact Test (if n < 5) for comparison of percentages. We used the Pearson or Sperman correlation to evaluate the relationship between the continuous variables.

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

入选标准

  • hospitalized patients with acute respiratory failure and COPD

排除标准

  • chronic renal failure
  • cirrhosis
  • inflammatory bowel disease

结局指标

主要结局

Correlation between BMI (Kg/m2) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD

时间窗: Baseline

BMI is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients

Correlation between arm circumference (cm) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD

时间窗: Baseline

Arm circumference is muscle mass related and is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients

Correlation between dynapenia using handgrip strength test (Kg) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD

时间窗: Baseline

The dynapenia is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients

Correlation between fat free mass (Kg) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD

时间窗: Baseline

Body composition (fat free mass) is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients

Correlation between albumin (g/dL) blood serum level on prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD

时间窗: Baseline

Albumin is very influenced by nutritional status and low blood level means that nutritional status is not good

Correlation between food Intake: as pergentage of ingesta in the last meal and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD

时间窗: Baseline

Food intake is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients

Correlation between tricipital skin fold thickness (mm) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD

时间窗: Baseline

Tricipital skin fold thickness is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients

次要结局

  • Correlation between diaphragm ultrasound performed during quiet respiration (mm) and arm circumference (cm) in hospitalized patients with acute respiratory failure and COPD(Baseline)
  • Correlation between diaphragm ultrasound performed during quiet respiration (mm) and BMI (Kg/m2) in hospitalized patients with acute respiratory failure and COPD(Baseline)
  • Correlation between diaphragm ultrasound performed during quiet respiration (mm) and body composition - fat free mass (Kg) in hospitalized patients with acute respiratory failure and COPD(Baseline)
  • Correlation between diaphragm ultrasound performed during quiet respiration (mm) and dynapenia using handgrip strength test (Kg) in hospitalized patients with acute respiratory failure and COPD(Baseline)
  • Correlation between diaphragm ultrasound performed during quiet respiration (mm) and food Intake: as pergentage of ingesta in the last meal in hospitalized patients with acute respiratory failure and COPD(Baseline)
  • Correlation between diaphragm ultrasound performed during quiet respiration (mm) and tricipital skin fold thickness (mm) in hospitalized patients with acute respiratory failure and COPD(Baseline)

研究者

发起方
Fondazione Fatebenefratelli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Di Lazzaro

Physician, Clinical Nutrition and Internal Medicine

Fondazione Fatebenefratelli

研究点 (1)

Loading locations...

相似试验