Risk Factors and Prediction Score of ARDS After Cardiac Surgery

Completed

• Conditions: Respiratory Distress Syndrome, Adult; Risk Factors; Thoracic Surgery
• Interventions: Other: no intervention

• Registration Number: NCT02759770
• Lead Sponsor: Beijing Anzhen Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-03
• Study Start: 2017-07-01
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2019-12
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1333

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
propective group	no intervention	patients of cardiac surgery including ARDS and non-ARDS patients
ARDS	no intervention	ARDS patients after cardiac surgery
non-ARDS	no intervention	non-ARDS patients after cardiac surgery

Primary Outcome Measures

Name	Time	Method
The process of operation in ARDS group.	up to 1 month
The number of chronic obstructive pulmonary disease patients in ARDS group.	up to 1 month
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 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 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

Name	Time	Method
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

Trial Locations

Locations (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, China