NCT00945529已完成2 期
The Effects of Inhaled Nitric Oxide on Patient Morbidity and Length of Hospital Stay Following Fontan Operation
Ellen Spurrier1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Length of Hospital Stay Following Fontan
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Any condition which the PI feels will interfere with the patient's safe and effective participation
研究组 & 干预措施
Intervention
Experimental
Prospective group who received iNO.
干预措施: inhaled nitric oxide (iNO) (Drug)
结局指标
主要结局
Length of Hospital Stay Following Fontan
时间窗: until hospital discharge
次要结局
- Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage(2 weeks)
研究者
Ellen Spurrier
Director of Cardiac Anesthesiology
Nemours Children's Clinic
研究点 (1)
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