Risk Factors and Prediction Score of ARDS After Cardiac Surgery
28 de enero de 2021 actualizado por: Guangfa Zhu, Beijing Anzhen Hospital
Acute respiratory distress syndrome following cardiac surgery severely affects the prognosis of patients; the mortality is up to 40%.
Although experience many years of research and exploration, the effective methods for the treatment of acute respiratory distress syndrome is still relatively limited at present, including lung protective mechanical ventilation respiratory support, fluid management, glucocorticoid and other integrated organ function maintenance measures.
It is currently the research of acute respiratory distress syndrome aims at the early discovery and takes effective measures to prevent its occurrence, hoping to improve the prognosis of patients.
According to risk factors is established through the analysis of lung injury score early warning system, the early identification of acute respiratory distress syndrome patients at high risk, before the occurrence of acute respiratory distress syndrome take corresponding preventive measures can effectively reduce the incidence rate and mortality.
So far, domestic and foreign research on the establishment of acute respiratory distress syndrome scoring early warning system is less.
Cardiac surgery has significant characteristics, type of operation, location, operation, intraoperative blood transfusion and oxygenation, postoperative factors, are likely to be the factors of acute respiratory distress syndrome.
As far as investigators know, so far there are few specialized for acute respiratory distress syndrome predicting lung injury after cardiac surgery.
This study will be completed after the implementation of individualized dynamic lung injury score evaluation of cardiac surgery patients, identification of high-risk acute respiratory distress syndrome patients, to assist clinicians in early decision, take preventive measures.
This study will improve the prognosis of acute respiratory distress syndrome patients after cardiac surgery; it is of great significance to improve the level of intensive care after cardiac surgery.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
1333
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100029
- Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients of cardiac surgery in Beijing Anzhen hospital
Descripción
Inclusion Criteria:
- Retrospective group: cardiac surgery patients accepted from Jan 2013 to Dec 2015
- Prospective group: cardiac surgery patients accepted from 2017 January to December
Exclusion Criteria:
- refused to participate in the study
- age less than 18 years old
- before operation performed mechanical ventilation
- before operation underwent IABP treatment
- before operation continuous renal replacement therapy
- before operation undergoing in vitro membrane oxygenator treatment
- before operation has the pulmonary imaging showed bilateral pulmonary diffuse exudation of interstitial pneumonia, pulmonary infection or respiratory failure
- the major trauma, sepsis, aspiration, shock, acute heart failure
- before operation diagnosed as malignant tumor
- Incomplete data.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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ARDS
ARDS patients after cardiac surgery
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This is a clinical observational study, no intervention was included.
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non-ARDS
non-ARDS patients after cardiac surgery
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This is a clinical observational study, no intervention was included.
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propective group
patients of cardiac surgery including ARDS and non-ARDS patients
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This is a clinical observational study, no intervention was included.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Periodo de tiempo: up to 12months
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up to 12months
|
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The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Periodo de tiempo: up to 12months
|
up to 12months
|
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The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
Periodo de tiempo: up to 12months
|
up to 12months
|
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The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
Periodo de tiempo: up to 12months
|
up to 12months
|
|
The number of diabetic patients in ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
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The number of diabetic patients in non-ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
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The number of chronic obstructive pulmonary disease patients in ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
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The number of chronic obstructive pulmonary disease patients in non-ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
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The type of operation in ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
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The type of operation in non-ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The body mass index in ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The body mass index in non-ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The heart function in ARDS group before operation.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
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The heart function in non-ARDS group before operation.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
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The oxygenation in ARDS group before operation.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The oxygenation in non-ARDS group before operation.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The drug taken by patients in ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The drug taken by patients in non-ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The nutrition situation of patients in ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The nutrition situation of patients in non-ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The process of operation in ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The process of operation in non-ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The blood transfusion of patients during operation in ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The blood transfusion of patients during operation in non-ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients during operation in ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients during operation in non-ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The drug taken by patients after operation in ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The drug taken by patients after operation in non-ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients after operation in ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients after operation in non-ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The situation of mechanical ventilation of patients after operation in ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
|
The situation of mechanical ventilation of patients after operation in non-ARDS group.
Periodo de tiempo: up to 1 month
|
up to 1 month
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Periodo de tiempo: up to 1months
|
up to 1months
|
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The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Periodo de tiempo: up to 1months
|
up to 1months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Guangfa Zhu, Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Kogan A, Preisman S, Levin S, Raanani E, Sternik L. Adult respiratory distress syndrome following cardiac surgery. J Card Surg. 2014 Jan;29(1):41-6. doi: 10.1111/jocs.12264. Epub 2013 Dec 3.
- Berg KS, Stenseth R, Pleym H, Wahba A, Videm V. Mortality risk prediction in cardiac surgery: comparing a novel model with the EuroSCORE. Acta Anaesthesiol Scand. 2011 Mar;55(3):313-21. doi: 10.1111/j.1399-6576.2010.02393.x.
- Forel JM, Voillet F, Pulina D, Gacouin A, Perrin G, Barrau K, Jaber S, Arnal JM, Fathallah M, Auquier P, Roch A, Azoulay E, Papazian L. Ventilator-associated pneumonia and ICU mortality in severe ARDS patients ventilated according to a lung-protective strategy. Crit Care. 2012 Dec 12;16(2):R65. doi: 10.1186/cc11312.
- Grissom CK, Hirshberg EL, Dickerson JB, Brown SM, Lanspa MJ, Liu KD, Schoenfeld D, Tidswell M, Hite RD, Rock P, Miller RR 3rd, Morris AH; National Heart Lung and Blood Institute Acute Respiratory Distress Syndrome Clinical Trials Network. Fluid management with a simplified conservative protocol for the acute respiratory distress syndrome*. Crit Care Med. 2015 Feb;43(2):288-95. doi: 10.1097/CCM.0000000000000715.
- Festic E, Kor DJ, Gajic O. Prevention of acute respiratory distress syndrome. Curr Opin Crit Care. 2015 Feb;21(1):82-90. doi: 10.1097/MCC.0000000000000174.
- Rubenfeld GD. Who cares about preventing acute respiratory distress syndrome? Am J Respir Crit Care Med. 2015 Feb 1;191(3):255-60. doi: 10.1164/rccm.201408-1574CP.
- Beitler JR, Schoenfeld DA, Thompson BT. Preventing ARDS: progress, promise, and pitfalls. Chest. 2014 Oct;146(4):1102-1113. doi: 10.1378/chest.14-0555.
- Milot J, Perron J, Lacasse Y, Letourneau L, Cartier PC, Maltais F. Incidence and predictors of ARDS after cardiac surgery. Chest. 2001 Mar;119(3):884-8. doi: 10.1378/chest.119.3.884.
- Michalopoulos A, Prapas S, Falagas ME. The incidence of adult respiratory distress syndrome in patients undergoing off-pump coronary artery bypass grafting surgery. Eur J Anaesthesiol. 2006 Jan;23(1):80. doi: 10.1017/S0265021505211821. No abstract available.
- Vakili M, Shirani S, Paknejad O, Yousefshahi F. Acute Respiratory Distress Syndrome diagnosis after coronary artery bypass: comparison between diagnostic criteria and clinical picture. Acta Med Iran. 2015;53(1):51-6.
- Kor DJ, Lingineni RK, Gajic O, Park PK, Blum JM, Hou PC, Hoth JJ, Anderson HL 3rd, Bajwa EK, Bartz RR, Adesanya A, Festic E, Gong MN, Carter RE, Talmor DS. Predicting risk of postoperative lung injury in high-risk surgical patients: a multicenter cohort study. Anesthesiology. 2014 May;120(5):1168-81. doi: 10.1097/ALN.0000000000000216.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de julio de 2017
Finalización primaria (Actual)
30 de septiembre de 2017
Finalización del estudio (Actual)
30 de septiembre de 2017
Fechas de registro del estudio
Enviado por primera vez
25 de abril de 2016
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2016
Publicado por primera vez (Estimar)
3 de mayo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de febrero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
28 de enero de 2021
Última verificación
1 de diciembre de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Shoufa-2016-2-1052
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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