Risk Factors and Prediction Score of ARDS After Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Adult; Risk Factors; Thoracic Surgery
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Actual): 1333

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of cardiac surgery in Beijing Anzhen hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARDS; ARDS patients after cardiac surgery	Other: no intervention; This is a clinical observational study, no intervention was included.
non-ARDS; non-ARDS patients after cardiac surgery	Other: no intervention; This is a clinical observational study, no intervention was included.
propective group; patients of cardiac surgery including ARDS and non-ARDS patients	Other: no intervention; This is a clinical observational study, no intervention was included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.	up to 12months
The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.	up to 12months
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.	up to 12months
The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.	up to 12months
The number of diabetic patients in ARDS group.	up to 1 month
The number of diabetic patients in non-ARDS group.	up to 1 month
The number of chronic obstructive pulmonary disease patients in ARDS group.	up to 1 month
The number of chronic obstructive pulmonary disease patients in non-ARDS group.	up to 1 month
The type of operation in ARDS group.	up to 1 month
The type of operation in non-ARDS group.	up to 1 month
The body mass index in ARDS group.	up to 1 month
The body mass index in non-ARDS group.	up to 1 month
The heart function in ARDS group before operation.	up to 1 month
The heart function in non-ARDS group before operation.	up to 1 month
The oxygenation in ARDS group before operation.	up to 1 month
The oxygenation in non-ARDS group before operation.	up to 1 month
The drug taken by patients in ARDS group.	up to 1 month
The drug taken by patients in non-ARDS group.	up to 1 month
The nutrition situation of patients in ARDS group.	up to 1 month
The nutrition situation of patients in non-ARDS group.	up to 1 month
The process of operation in ARDS group.	up to 1 month
The process of operation in non-ARDS group.	up to 1 month
The blood transfusion of patients during operation in ARDS group.	up to 1 month
The blood transfusion of patients during operation in non-ARDS group.	up to 1 month
The oxygenation of patients during operation in ARDS group.	up to 1 month
The oxygenation of patients during operation in non-ARDS group.	up to 1 month
The drug taken by patients after operation in ARDS group.	up to 1 month
The drug taken by patients after operation in non-ARDS group.	up to 1 month
The oxygenation of patients after operation in ARDS group.	up to 1 month
The oxygenation of patients after operation in non-ARDS group.	up to 1 month
The situation of mechanical ventilation of patients after operation in ARDS group.	up to 1 month
The situation of mechanical ventilation of patients after operation in non-ARDS group.	up to 1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .	up to 1months
The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .	up to 1months

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Study Chair: Guangfa Zhu, Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: Shoufa-2016-2-1052