Association Between Body Mass Index and HFNC Therapy Success
2021年3月11日 更新者:Carlos Augusto Celemín Florez, MD.、Clínica del country
Association Between Body Mass Index and High-flow Cannula Therapy Success in Patients With Severe Covid 19 Related Pneumonia. Retrospective Study.
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.
研究概览
详细说明
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
研究类型
观察性的
注册 (实际的)
303
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Bogotá、哥伦比亚
- Clínica del Country.
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Primary outcome
大体时间:1 year.
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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.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Demographic and laboratory characteristics
大体时间: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.
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1 year
|
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Body mass index as a predictor
大体时间:1 year
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Evaluate the body mass index as a predictor of success in high-flow cannula therapy.
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1 year
|
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Body mass index and HFNC success
大体时间:1 year
|
Evaluate the relationship between body mass index and high-flow nasal cannula therapy success.
|
1 year
|
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Mortality
大体时间:1 year
|
Describe the mortality of patients with high-flow cannula therapy in our medical facilities.
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1 year
|
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Hospital stay.
大体时间:1 year
|
The relationship between hospital stay (days) and body mass index in our patients' cohort will be evaluated.
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1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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;:
- 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.
- 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.
- 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.
- 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.
- Smati S, Tramunt B, Wargny M, Caussy C, Gaborit B, Vatier C, Verges 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-Begue 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.
- 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):280. doi: 10.3390/biology9090280.
- 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.
- 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.
- 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. Erratum In: Obes Rev. 2021 Oct;22(10):e13305.
- 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.
- 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.
- 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.
- Contou D, Cally R, Sarfati F, Desaint P, Fraisse M, Plantefeve 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. No abstract available.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年3月11日
初级完成 (实际的)
2021年3月1日
研究完成 (实际的)
2021年3月1日
研究注册日期
首次提交
2021年3月9日
首先提交符合 QC 标准的
2021年3月11日
首次发布 (实际的)
2021年3月16日
研究记录更新
最后更新发布 (实际的)
2021年3月16日
上次提交的符合 QC 标准的更新
2021年3月11日
最后验证
2021年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.