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OpenTrials
Completed

NCT Number: NCT04799132

Association Between Body Mass Index and HFNC Therapy Success

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years of age.
  • 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.
  • Patient admission to the Clinical del Country and Clinica de la Colina intermediate care units.
  • Oxygen therapy by high-flow system (high-flow cannula) requirement.
  • Anthropometric data availability upon admission to our facilities.

Exclusion criteria

  • Patients with a survival expectancy of less than 12 months according to the Charlson scale categorization or patients with oncological pathology.
  • Patients under 18 years of age.
  • Pregnant women.
  • Patients with cardiogenic pulmonary edema.
  • History of chronic liver disease or cirrhosis Child - Pugh C.
  • Patients with contraindications to high-flow cannula therapy initiation.
  • Patients with respiratory, hemodynamic and neurological indications that contraindicate HFNC initiation.

Treatment and study plan

Primary outcomes

  1. Primary outcome

    Time frame: 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 outcomes

  1. Demographic and laboratory characteristics

    Time frame: 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

    Time frame: 1 year

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

  3. Body mass index and HFNC success

    Time frame: 1 year

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

  4. Mortality

    Time frame: 1 year

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

  5. Hospital stay.

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Clínica del country

Other

Registry information

Official study title

Association Between Body Mass Index and High-flow Cannula Therapy Success in Patients With Severe Covid 19 Related Pneumonia. Retrospective Study.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2021
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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