Risk Factors and Prediction Score of ARDS After Cardiac Surgery

NCT02759770 | Completed

• 1 other identifier: Shoufa-2016-2-1052
• Study Type: observational
• Target: 1,333
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Distress Syndrome, Adult; Thoracic Surgery; Risk Factors

Outcome Measures

Primary Outcomes (32)

• 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 Outcomes (2)

• 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

Study Arms (3)

ARDS

ARDS patients after cardiac surgery

Other: no intervention

non-ARDS

non-ARDS patients after cardiac surgery

Other: no intervention

propective group

patients of cardiac surgery including ARDS and non-ARDS patients

Other: no intervention

Interventions

no intervention OTHER

This is a clinical observational study, no intervention was included.

ARDS; non-ARDS; propective group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of cardiac surgery in Beijing Anzhen hospital

You may qualify if:

• Retrospective group: cardiac surgery patients accepted from Jan 2013 to Dec 2015
• Prospective group: cardiac surgery patients accepted from 2017 January to December

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (12)

• 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.

  PMID: 24299028 BACKGROUND

• 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.

  PMID: 21288212 BACKGROUND

• 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.

  PMID: 22524447 BACKGROUND

• 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.

  PMID: 25599463 BACKGROUND

• 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.

  PMID: 25501020 BACKGROUND

• 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.

  PMID: 25478722 BACKGROUND

• 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.

  PMID: 25288000 BACKGROUND

• 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.

  PMID: 22797452 BACKGROUND

• 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.

  PMID: 11243972 BACKGROUND

• 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.

  PMID: 16390572 BACKGROUND

• 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.

  PMID: 25597606 BACKGROUND

• 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.

  PMID: 24755786 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Guangfa Zhu

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 3, 2016
• Study Start: July 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: February 1, 2021

Record last verified: 2019-12

Locations

CN (1)