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

Patients Who Underwent Surgery for Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081274
• Other study ID #: 2013-12-146
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: April 24, 2017
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Defects, Congenital
• Heart Diseases
• Patients Who Underwent Surgery for Congenital Heart Disease

Intervention

Procedure:
• Surgery for congenital heart disease

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Mortality	Patient Mortality at six month after surgery	six month after surgery
Secondary	Patient Mortality	In-hospital, one-month and one-year mortality after surgery	in-hospital, one-month, and one-year after surgery
Secondary	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