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

NCT ID: NCT04639648

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-05-02

Brief Summary

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.

Detailed Description

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.

Ethical approval and consent to participate All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and the national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Conditions

Malnutrition; COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• hospitalized patients with acute respiratory failure and COPD

Exclusion Criteria

• chronic renal failure
• cancer
• cirrhosis
• inflammatory bowel disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Fatebenefratelli

OTHER

Sponsor Role: lead

Responsible Party

Luca Di Lazzaro

Physician, Clinical Nutrition and Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dario Manfellotto, MD

Role: STUDY_DIRECTOR

Fatebenefratelli San Giovanni Calibita Hospital

Locations

Fatebenefratelli San Giovanni Calibita-Isola Tiberina Hospital

Rome, Lazio, Italy

Countries

Italy

Other Identifiers

1465/CE Lazio 1

Identifier Type: -

Identifier Source: org_study_id