Influence of Tidal Volume During Mechanical Ventilation on Postoperative Clinical Outcome in Pediatric Patients Undergoing Congenital Heart Surgery

Study Overview
=================
Brief Summary
-----------------
High tidal volume during mechanical ventilation has been reported to increase mortality in patients with acute lung injury or acute respiratory distress syndrome. High tidal volume was also reported to be associated with increased mortality in adult patients without acute lung injury or acute respiratory distress syndrome. However, the influence of high tidal volume on clinical outcome in pediatric patients who underwent surgery for congenital heart disease has not been evaluated yet. The investigators attempted to evaluate the effect of tidal volume on clinical outcome in both cyanotic and non-cyanotic congenital heart disease.

Detailed Description
-----------------
High tidal volume during mechanical ventilation has been reported to increase mortality in patients with acute lung injury or acute respiratory distress syndrome. High tidal volume was also reported to be associated with increased mortality in adult patients without acute lung injury or acute respiratory distress syndrome. However, the influence of high tidal volume on clinical outcome in pediatric patients who underwent surgery for congenital heart disease has not been evaluated yet. The investigators attempted to evaluate the effect of tidal volume on clinical outcome in both cyanotic and non-cyanotic congenital heart disease.

Official Title
-----------------
Influence of Tidal Volume During Mechanical Ventilation on Postoperative Clinical Outcome in Pediatric Patients Undergoing Congenital Heart Surgery

Conditions
-----------------
Patients Who Underwent Surgery for Congenital Heart Disease

Intervention / Treatment
-----------------
* Procedure: Surgery for congenital heart disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients who underwent surgery for congenital heart disease with cardiopulmonary bypass between 2009 and 2013 in Samsung Medical Center Exclusion Criteria: patients who lack data regarding mortality, creatinine, estimated glomerular filtration rate, or urine output.

Ages Eligible for Study
-----------------
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients who underwent surgery for congenital heart disease<br>patients who underwent surgery for congenital heart disease between 2009 and 2013 in Samsung Medical Center | Procedure: Surgery for congenital heart disease<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Mortality | Patient Mortality at six month after surgery | six month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Mortality | In-hospital, one-month and one-year mortality after surgery | in-hospital, one-month, and one-year after surgery | 
| acute kidney injury as defined by RIFLE criteria (for Risk, Injury, Failure, Loss, End-stage kidney disease) | acute kidney injury as defined by RIFLE criteria (for Risk, Injury, Failure, Loss, End-stage kidney disease) | during one week after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tidal volume, congenital heart disease, mortality