Association Between Body Mass Index and HFNC Therapy Success

Sponsor
Clínica del country (Other)
Overall Status
Completed
CT.gov ID
NCT04799132
Collaborator
(none)
303
1
11.7
26

Study Details

Study Description

Brief Summary

Patients over 18 years of age who are admitted to the Intermediate Care Unit of the Clinica del Country and the Clinica la Colina, with symptoms suggestive of severe pneumonia secondary to COVID-19 infection and acute hypoxemic respiratory failure. The primary outcome will be to determine the relationship between body mass index and high-flow cannula therapy success defined as: No need for mechanical ventilation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All adult patients over 18 years of age admitted to the intermediate care service of the participating center with suspected SARS-CoV-2 pneumonia will be considered as potential candidates for the study.

    The medical records of patients in our cohort who require high-flow cannula therapy and who met all the inclusion criteria and none of the exclusion criteria will be reviewed.All data will be processed and analyzed using the SPSS 26 software once the study is completed. study sample

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    303 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Association Between Body Mass Index and High-flow Cannula Therapy Success in Patients With Severe Covid 19 Related Pneumonia. Retrospective Study.
    Actual Study Start Date :
    Mar 11, 2020
    Actual Primary Completion Date :
    Mar 1, 2021
    Actual Study Completion Date :
    Mar 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Primary outcome [1 year.]

      To determine the relationship between body mass index "BMI" calculated by kg / m2 (BMI was classified in the following categories: normal weight: 18.5-24.9 kg / m2, overweight: 25-29.9 kg / m2, and obesity: ≥ 30 kg / m2) and high-flow cannula therapy success defined as: No need for mechanical ventilation.

    Secondary Outcome Measures

    1. Demographic and laboratory characteristics [1 year]

      Describe the clinical, demographic and laboratory characteristics in a population of 303 patients in Bogotá, Colombia with severe pneumonia defined by ATS criteria (confusion, urea >7 mmol/L, respiratory rate ≥30 min-1, low blood pressure, and age ≥65 years) score except age, arterial oxygen pressure/fraction inspired oxygen (PaO2/FiO2) ≤250 mmHg, multilobar infiltrates, leucopenia, thrombocytopenia, and hypothermia.) secondary to COVID 19 infection (positive C-Reactive protein) and acute hypoxemic respiratory failure defined by a PaFio2 < 300, in the intermediate care service of the Clínica del Country and Clínica La Colina, between March 2020 and March 2021.

    2. Body mass index as a predictor [1 year]

      Evaluate the body mass index as a predictor of success in high-flow cannula therapy.

    3. Body mass index and HFNC success [1 year]

      Evaluate the relationship between body mass index and high-flow nasal cannula therapy success.

    4. Mortality [1 year]

      Describe the mortality of patients with high-flow cannula therapy in our medical facilities.

    5. Hospital stay. [1 year]

      The relationship between hospital stay (days) and body mass index in our patients' cohort will be evaluated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patients over 18 years of age.

    2. Diagnosis of severe pneumonia secondary to COVID-19 infection and acute respiratory distress syndrome, defined by upper and lower respiratory symptoms plus positive C-reactive protein test for COVID-19.

    3. Patient admission to the Clinical del Country and Clinica de la Colina intermediate care units.

    4. Oxygen therapy by high-flow system (high-flow cannula) requirement.

    5. Anthropometric data availability upon admission to our facilities.

    Exclusion Criteria:
    1. Patients with a survival expectancy of less than 12 months according to the Charlson scale categorization or patients with oncological pathology.

    2. Patients under 18 years of age.

    3. Pregnant women.

    4. Patients with cardiogenic pulmonary edema.

    5. History of chronic liver disease or cirrhosis Child - Pugh C.

    6. Patients with contraindications to high-flow cannula therapy initiation.

    7. Patients with respiratory, hemodynamic and neurological indications that contraindicate HFNC initiation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clínica del Country. Bogotá Colombia

    Sponsors and Collaborators

    • Clínica del country

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Carlos Augusto Celemín Florez, MD., Principal Investigator., Clínica del country
    ClinicalTrials.gov Identifier:
    NCT04799132
    Other Study ID Numbers:
    • BMI AND HFNC
    First Posted:
    Mar 16, 2021
    Last Update Posted:
    Mar 16, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 16, 2021