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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02081274
Enrollment
1000
Registered
2014-03-07
Start date
2014-01-31
Completion date
2016-12-31
Last updated
2017-04-25

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

Conditions

Patients Who Underwent Surgery for Congenital Heart Disease

Keywords

tidal volume, congenital heart disease, mortality

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.

Interventions

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Mortalitysix month after surgeryPatient Mortality at six month after surgery

Secondary

MeasureTime frameDescription
Patient Mortalityin-hospital, one-month, and one-year after surgeryIn-hospital, one-month and one-year mortality after surgery
acute kidney injury as defined by RIFLE criteria (for Risk, Injury, Failure, Loss, End-stage kidney disease)during one week after surgeryacute kidney injury as defined by RIFLE criteria (for Risk, Injury, Failure, Loss, End-stage kidney disease)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026