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Association Between Body Mass Index and HFNC Therapy Success

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ClinicalTrials.gov Identifier: NCT04799132
Recruitment Status : Completed
First Posted : March 16, 2021
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Carlos Augusto Celemín Florez, MD., Clínica del country

Tracking Information
First Submitted Date March 9, 2021
First Posted Date March 16, 2021
Last Update Posted Date March 16, 2021
Actual Study Start Date March 11, 2020
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2021)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 11, 2021)
  • 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.
  • 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.
  • Body mass index and HFNC success [ Time Frame: 1 year ]
    Evaluate the relationship between body mass index and high-flow nasal cannula therapy success.
  • Mortality [ Time Frame: 1 year ]
    Describe the mortality of patients with high-flow cannula therapy in our medical facilities.
  • Hospital stay. [ Time Frame: 1 year ]
    The relationship between hospital stay (days) and body mass index in our patients' cohort will be evaluated.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Association Between Body Mass Index and HFNC Therapy Success
Official Title Association Between Body Mass Index and High-flow Cannula Therapy Success in Patients With Severe Covid 19 Related Pneumonia. Retrospective Study.
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Covid19
  • Obesity
  • Overweight
  • Pneumonia, Viral
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 11, 2021)
303
Original Actual Enrollment Same as current
Actual Study Completion Date March 1, 2021
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Colombia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04799132
Other Study ID Numbers BMI AND HFNC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Carlos Augusto Celemín Florez, MD., Clínica del country
Study Sponsor Clínica del country
Collaborators Not Provided
Investigators Not Provided
PRS Account Clínica del country
Verification Date March 2021