The Effects of Inhaled Nitric Oxide After Fontan Operation

Ellen Spurrier21 enrolled

Overview

Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after Fontan operation will improve fluid balance, thus decreasing the incidence of pleural effusions and shortening hospital stay.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congenital Heart Defect

Interventions

inhaled nitric oxide (iNO)DRUG

Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.

Eligibility

Sex: ALLMin age: 1 YearMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male/female patients * Undergoing Fontan operation at the Nemours Cardiac Center at A. I. duPont Hospital for Children * Written parental permission to participate in this research study Exclusion Criteria: * Any condition which the PI feels will interfere with the patient's safe and effective participation

Locations (1)

A. I. duPont Hospital for Children/Nemours Cardiac Center

Wilmington, Delaware, United States

Outcomes

Primary Outcomes

Length of Hospital Stay Following Fontan

Time frame: until hospital discharge

Secondary Outcomes

Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage

Percent of patients with significant pleural fluid collections that required thoracostomy drainage

Time frame: 2 weeks

Data from ClinicalTrials.gov

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