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Clinical Trials/NCT02081274
NCT02081274
Completed
Not Applicable

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

Samsung Medical Center1 site in 1 country1,000 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients Who Underwent Surgery for Congenital Heart Disease
Sponsor
Samsung Medical Center
Enrollment
1000
Locations
1
Primary Endpoint
Patient Mortality
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
December 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

WonHo Kim

Assistant Professor

Samsung Medical Center

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.

Outcomes

Primary Outcomes

Patient Mortality

Time Frame: six month after surgery

Patient Mortality at six month after surgery

Secondary Outcomes

  • Patient Mortality(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)(during one week after surgery)

Study Sites (1)

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