Skip to content

Lung protective ventilation strategy in infants undergoing congenital heart disease operation with cadiopulmonary bypass

Lung protective ventilation strategy in infants undergoing congenital heart disease operation with cadiopulmonary bypass

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013194
Enrollment
Unknown
Registered
2017-10-31
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary dysfunction after cardiopulmonary bypass

Interventions

protective ventilation group:small tidal volume ventilation
protective ventilation group:alveolar recruitment maneuver using incremental PEEP
protective ventilation group:ventilated with optimal PEEP

Sponsors

Department of Anesthesiology and Critical Care Medicine, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine,China.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: We will recruit 120 patients (year=1) that undergo the radical surgery therapy through median sternotomy with CPB in this study. The patients who undergo the surgery without CPB (ligation of patent ductus arteriosus, coarctation of aorta) or with the palliative surgery(pulmonary artery banding, systemic-to-pulmonary shunting) will not recruited in our study. The written consent from the childrens statutory guadians should be obtained before the recruitement.;Inclusion criteria: We will recruit 120 patients (year=1) that undergo the radical surgery therapy through median sternotomy with CPB in this study. The patients who undergo the surgery without CPB (ligation of patent ductus arteriosus, coarctation of aorta) or with the palliative surgery(pulmonary artery banding, systemic-to-pulmonary shunting) will not recruited in our study. The written consent from the childrens statutory guadians should be obtained before the recruitement.;Inclusion criteria: We will recruit 120 patients (year=1) that undergo the radical surgery therapy through median sternotomy with CPB in this study. The patients who undergo the surgery without CPB (ligation of patent ductus arteriosus, coarctation of aorta) or with the palliative surgery(pulmonary artery banding, systemic-to-pulmonary shunting) will not recruited in our study. The written consent from the childrens statutory guadians should be obtained before the recruitement.;Inclusion criteria: We will recruit 120 patients (year=1) that undergo the radical surgery therapy through median sternotomy with CPB in this study. The patients who undergo the surgery without CPB (ligation of patent ductus arteriosus, coarctation of aorta) or with the palliative surgery(pulmonary artery banding, systemic-to-pulmonary shunting) will not recruited in our study. The written consent from the childrens statutory guadians should be obtained before the recruitement.;Inclusion criteria: We will recruit 120 patients (year=1) that undergo the radical surgery therapy through median sternotomy with CPB in this study. The patients who undergo the surgery without CPB (ligation of patent ductus arteriosus, coarctation of aorta) or with the palliative surgery(pulmonary artery banding, systemic-to-pulmonary shunting) will not recruited in our study. The written consent from the childrens statutory guadians should be obtained before the recruitement.

Exclusion criteria

Exclusion criteria: 1. The childrens statutory guadians refuse to sign informed consent perioperatively; 2. The children have residual intracardiac shunt right to left diagnosed by transesophageal ultrasonic examination(TEE) intraoperatively or by echocardiography examination postoperatively; 3. The children are left ventricular dysfunctional [defined as left ventricular ejection fraction (LVEF )<50%]diagnosed by echocardiography postoperatively; 4. The children have severe complications during protective lung ventilation intervention( defined as the complications can not be relieved with the conventional dose of vasoactive agents or chest drainage, and last at least 3 minutes as well), including hypotension, bradycardia, arrhythemia, pneumothorax and pneumomediastinum.;Exclusion criteria: 1. The childrens statutory guadians refuse to sign informed consent perioperatively; 2. The children have residual intracardiac shunt right to left diagnosed by transesophageal ultrasonic examination(TEE) intraoperatively or by echocardiography examination postoperatively; 3. The children are left ventricular dysfunctional [defined as left ventricular ejection fraction (LVEF )<50%]diagnosed by echocardiography postoperatively; 4. The children have severe complications during protective lung ventilation intervention( defined as the complications can not be relieved with the conventional dose of vasoactive agents or chest drainage, and last at least 3 minutes as well), including hypotension, bradycardia, arrhythemia, pneumothorax and pneumomediastinum.;Exclusion criteria: 1. The childrens statutory guadians refuse to sign informed consent perioperatively; 2. The children have residual intracardiac shunt right to left diagnosed by transesophageal ultrasonic examination(TEE) intraoperatively or by echocardiography examination postoperatively; 3. The children are left ventricular dysfunctional [defined as left ventricular ejection fraction (LVEF )<50%]diagnosed by echocardiography postoperatively; 4. The children have severe complications during protective lung ventilation intervention( defined as the complications can not be relieved with the conventional dose of vasoactive agents or chest drainage, and last at least 3 minutes as well), including hypotension, bradycardia, arrhythemia, pneumothorax and pneumomediastinum.;Exclusion criteria: 1. The childrens statutory guadians refuse to sign informed consent perioperatively; 2. The children have residual intracardiac shunt right to left diagnosed by transesophageal ultrasonic examination(TEE) intraoperatively or by echocardiography examination postoperatively; 3. The children are left ventricular dysfunctional [defined as left ventricular ejection fraction (LVEF )<50%]diagnosed by echocardiography postoperatively; 4. The children have severe complications during protective lung ventilation intervention( defined as the complications can not be relieved with the conventional dose of vasoactive agents or chest drainage, and last at least 3 minutes as well), including hypotension, bradycardia, arrhythemia, pneumothorax and pneumomediastinum.;Exclusion criteria: 1. The childrens statutory guadians refuse to sign informed consent perioperatively; 2. The children have residual intracardiac shunt right to left diagnosed by transesophageal ultrasonic examination(TEE) intraoperatively or by echocardiography examination postoperatively; 3. The children are left ventricular dysfunctional [defined as left ventricular ejection fraction (LVEF )<50%]diagnosed by echocardiography postoperatively; 4. The children have severe complications during protective lung ventilation intervention( defined as the complications can not be relieved with the conventional dose of vasoactive agents or chest drainage, and last at least 3 minutes as well), including hypotension, bradycardia, arrhythemia, pneumothorax and pneumomediastinum.

Design outcomes

Primary

MeasureTime frame
PaO2/FiO2;

Secondary

MeasureTime frame
Ppeak;Cdyn;A-aDO2;Pa-ETCO2;

Countries

China

Contacts

Public ContactSun Yuan;Sun Yuan;Sun Yuan;Sun Yuan;Sun Yuan ;;;;

Department of Anesthesiology and Critical Care Medicine, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine,China.;Department of Anesthesiology and Critical Care Medicine, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine,China.;Department of Anesthesiology and Critical Care Medicine, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine,China.;Department of Anesthesiology and Critical Care Medicine, Xin Hua Hospit

sunyuan01@xinhuamed.com.cn;sunyuan01@xinhuamed.com.cn;sunyuan01@xinhuamed.com.cn;sunyuan01@xinhuamed.com.cn;sunyuan01@xinhuamed.com.cn+86 13917185896;+86 13917185896;+86 13917185896;+86 13917185896;+86 13917185896

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026