Association Between Body Mass Index and HFNC Therapy Success

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04799132
• Other study ID #: BMI AND HFNC
• Status: Completed
• Start date: March 11, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Clínica del country
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Obesity
• Overweight
• Pneumonia
• Pneumonia, Viral

Locations

Country	Name	City	State
Colombia	Clínica del Country.	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Clínica del country

Country where clinical trial is conducted

Colombia, 

References & Publications (17)

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30. — View Citation

Contou D, Cally R, Sarfati F, Desaint P, Fraissé M, Plantefève G. Causes and timing of death in critically ill COVID-19 patients. Crit Care. 2021 Feb 23;25(1):79. doi: 10.1186/s13054-021-03492-x. — View Citation

Cummings MJ, Baldwin MR, Abrams D, Jacobson SD, Meyer BJ, Balough EM, Aaron JG, Claassen J, Rabbani LE, Hastie J, Hochman BR, Salazar-Schicchi J, Yip NH, Brodie D, O'Donnell MR. Epidemiology, clinical course, and outcomes of critically ill adults with COVID-19 in New York City: a prospective cohort study. Lancet. 2020 Jun 6;395(10239):1763-1770. doi: 10.1016/S0140-6736(20)31189-2. Epub 2020 May 19. — View Citation

Dale CR, Starcher RW, Chang SC, Robicsek A, Parsons G, Goldman JD, Vovan A, Hotchkin D, Gluckman TJ. Surge effects and survival to hospital discharge in critical care patients with COVID-19 during the early pandemic: a cohort study. Crit Care. 2021 Feb 17;25(1):70. doi: 10.1186/s13054-021-03504-w. — View Citation

de Frel DL, Atsma DE, Pijl H, Seidell JC, Leenen PJM, Dik WA, van Rossum EFC. The Impact of Obesity and Lifestyle on the Immune System and Susceptibility to Infections Such as COVID-19. Front Nutr. 2020 Nov 19;7:597600. doi: 10.3389/fnut.2020.597600. eCollection 2020. Review. — View Citation

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:. — View Citation

Kompaniyets L, Goodman AB, Belay B, Freedman DS, Sucosky MS, Lange SJ, Gundlapalli AV, Boehmer TK, Blanck HM. Body Mass Index and Risk for COVID-19-Related Hospitalization, Intensive Care Unit Admission, Invasive Mechanical Ventilation, and Death - United States, March-December 2020. MMWR Morb Mortal Wkly Rep. 2021 Mar 12;70(10):355-361. doi: 10.15585/mmwr.mm7010e4. — View Citation

Magdy Beshbishy A, Hetta HF, Hussein DE, Saati AA, C Uba C, Rivero-Perez N, Zaragoza-Bastida A, Shah MA, Behl T, Batiha GE. Factors Associated with Increased Morbidity and Mortality of Obese and Overweight COVID-19 Patients. Biology (Basel). 2020 Sep 9;9(9). pii: E280. doi: 10.3390/biology9090280. Review. — View Citation

Nogueira-de-Almeida CA, Del Ciampo LA, Ferraz IS, Del Ciampo IRL, Contini AA, Ued FDV. COVID-19 and obesity in childhood and adolescence: a clinical review. J Pediatr (Rio J). 2020 Sep - Oct;96(5):546-558. doi: 10.1016/j.jped.2020.07.001. Epub 2020 Aug 4. Review. — View Citation

Petrakis D, Margina D, Tsarouhas K, Tekos F, Stan M, Nikitovic D, Kouretas D, Spandidos DA, Tsatsakis A. Obesity - a risk factor for increased COVID-19 prevalence, severity and lethality (Review). Mol Med Rep. 2020 Jul;22(1):9-19. doi: 10.3892/mmr.2020.11127. Epub 2020 May 5. Review. — View Citation

Popkin BM, Du S, Green WD, Beck MA, Algaith T, Herbst CH, Alsukait RF, Alluhidan M, Alazemi N, Shekar M. Individuals with obesity and COVID-19: A global perspective on the epidemiology and biological relationships. Obes Rev. 2020 Nov;21(11):e13128. doi: 10.1111/obr.13128. Epub 2020 Aug 26. Review. — View Citation

Rochwerg B, Einav S, Chaudhuri D, Mancebo J, Mauri T, Helviz Y, Goligher EC, Jaber S, Ricard JD, Rittayamai N, Roca O, Antonelli M, Maggiore SM, Demoule A, Hodgson CL, Mercat A, Wilcox ME, Granton D, Wang D, Azoulay E, Ouanes-Besbes L, Cinnella G, Rauseo M, Carvalho C, Dessap-Mekontso A, Fraser J, Frat JP, Gomersall C, Grasselli G, Hernandez G, Jog S, Pesenti A, Riviello ED, Slutsky AS, Stapleton RD, Talmor D, Thille AW, Brochard L, Burns KEA. The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline. Intensive Care Med. 2020 Dec;46(12):2226-2237. doi: 10.1007/s00134-020-06312-y. Epub 2020 Nov 17. — View Citation

Sales-Peres SHC, de Azevedo-Silva LJ, Bonato RCS, Sales-Peres MC, Pinto ACDS, Santiago Junior JF. Coronavirus (SARS-CoV-2) and the risk of obesity for critically illness and ICU admitted: Meta-analysis of the epidemiological evidence. Obes Res Clin Pract. 2020 Sep - Oct;14(5):389-397. doi: 10.1016/j.orcp.2020.07.007. Epub 2020 Aug 3. — View Citation

Smati S, Tramunt B, Wargny M, Caussy C, Gaborit B, Vatier C, Vergès B, Ancelle D, Amadou C, Bachir LA, Bourron O, Coffin-Boutreux C, Barraud S, Dorange A, Fremy B, Gautier JF, Germain N, Larger E, Laugier-Robiolle S, Meyer L, Monier A, Moura I, Potier L, Sabbah N, Seret-Bégué D, Winiszewski P, Pichelin M, Saulnier PJ, Hadjadj S, Cariou B, Gourdy P; CORONADO investigators. Relationship between obesity and severe COVID-19 outcomes in patients with type 2 diabetes: Results from the CORONADO study. Diabetes Obes Metab. 2021 Feb;23(2):391-403. doi: 10.1111/dom.14228. Epub 2020 Nov 6. — View Citation

Williamson EJ, Walker AJ, Bhaskaran K, Bacon S, Bates C, Morton CE, Curtis HJ, Mehrkar A, Evans D, Inglesby P, Cockburn J, McDonald HI, MacKenna B, Tomlinson L, Douglas IJ, Rentsch CT, Mathur R, Wong AYS, Grieve R, Harrison D, Forbes H, Schultze A, Croker R, Parry J, Hester F, Harper S, Perera R, Evans SJW, Smeeth L, Goldacre B. Factors associated with COVID-19-related death using OpenSAFELY. Nature. 2020 Aug;584(7821):430-436. doi: 10.1038/s41586-020-2521-4. Epub 2020 Jul 8. — View Citation

Xia J, Zhang Y, Ni L, Chen L, Zhou C, Gao C, Wu X, Duan J, Xie J, Guo Q, Zhao J, Hu Y, Cheng Z, Zhan Q. High-Flow Nasal Oxygen in Coronavirus Disease 2019 Patients With Acute Hypoxemic Respiratory Failure: A Multicenter, Retrospective Cohort Study. Crit Care Med. 2020 Nov;48(11):e1079-e1086. doi: 10.1097/CCM.0000000000004558. — View Citation

Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome	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.	1 year.
Secondary	Demographic and laboratory characteristics	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.	1 year
Secondary	Body mass index as a predictor	Evaluate the body mass index as a predictor of success in high-flow cannula therapy.	1 year
Secondary	Body mass index and HFNC success	Evaluate the relationship between body mass index and high-flow nasal cannula therapy success.	1 year
Secondary	Mortality	Describe the mortality of patients with high-flow cannula therapy in our medical facilities.	1 year
Secondary	Hospital stay.	The relationship between hospital stay (days) and body mass index in our patients' cohort will be evaluated.	1 year