跳至主要内容
临床试验/NCT03180385
NCT03180385终止不适用

Neurally Adjusted Ventilatory Assist (NAVA) Versus Conventional Biphasic Positive End Expiratory Pressure (BiPAP) Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery

Children's Hospitals and Clinics of Minnesota2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
2
主要终点
Length of Intubation

研究概览

简要总结

Pediatric patients often require prolonged mechanical ventilation after cardiac surgery which comes with many undesirable effects. As a result, neurally-adjusted ventilatory assist (NAVA) and biphasic positive airway pressure support (BiPAP) have been developed as non-invasive alternatives to providing respiratory support post-operatively. The investigators hypothesize that providing synchronized biphasic support with NAVA will be associated with shorter duration of non-invasive respiratory support, less sedation requirements, and reduced length of hospital stay. This is a prospective, randomized study. Subjects are randomized to receive either NAVA or BiPAP following their cardiothoracic surgery.

详细描述

Mechanical ventilation is often very necessary in the care of critically ill pediatric patients. However, it comes with many different complications that include chronic lung disease, tissue damage, and ventilator-associated pneumonia. Over time, we have increased our understanding of how a child's physiology interacts with a ventilator and this has led to two different non-invasive forms of respiratory support: bilevel positive air pressure (BiPAP) and neurally adjusted ventilator assist (NAVA). While both modalities come with a lot of benefits such as improved gas exchange, decreased respiratory and heart rate and decreased inspiratory work of breathing, NAVA has the ability to provide synchronous ventilatory support due to the electrical activity of the diaphragm.

The purpose of this study is to compare clinical outcomes following use of NAVA versus BiPAP in patients undergoing cardiac surgery, Specifically, comparisons of non-invasive respiratory support, duration of sedation, and length of hospital stay. The investigators hypothesize that the use of NAVA will lead to a shorter duration of non-invasive respiratory support, less sedation requirements, and reduced length of hospital stay compared to the use of BiPAP.

This is a single-site, prospective randomized study. Subjects are randomized into two arms: those who receive NAVA and those who receive BiPAP post-operatively.

Subjects will be followed for up to 14 days post-operatively or until they are discharged, whichever comes first. Pain medication administered, FLACC (Face, Legs, Activity, Cry, Consolability), and SBS (State Behavioral Scale) scores are recorded daily for up to 14 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Postoperative cardiac surgery patients admitted to the Cardiovascular Care Center (CVCC) at Children's Hospitals and Clinics of Minnesota
  • Recommended for non-invasive (NIV) respiratory support following extubation, per provider discretion
  • 0 to 12 months of age

排除标准

  • Documented airway malformation (congenital or acquired)
  • Laryngomalacia
  • Bronchomalacia
  • Laryngeal web
  • Tracheal or bronchial rings (complete or incomplete)
  • Documented ENT abnormality
  • Documented central apnea
  • Patients who are overly sedated, per provider discretion
  • Tracheostomy in place at time of cardiac surgery
  • Documented phrenic nerve paralysis (Note: Vocal cord paresis and paralysis will not be an exclusion)
  • Other chromosomal abnormality (non-Down syndrome)
  • Chronic lung disease
  • Pre-operative non-invasive respiratory support

结局指标

主要结局

Length of Intubation

时间窗: Up to 14 days post-operatively

Average Post-operative Morphine Dose

时间窗: Up to 14 days post-operatively

Average Post-operative Midazolam Dose

时间窗: Up to 14 days post-operatively

Post-operative Pain Scores-FLACC

时间窗: Up to 14 days post-operatively

FLACC (Face, Legs, Activity, Cry, Consolability) scale

Average Post-operative Lorazepam Dose

时间窗: Up to 14 days post-operatively

Average Post-operative PCA Fentanyl Dose

时间窗: Up to 14 days post-operatively

Post-operative Sedation Scores-SBS

时间窗: Up to 14 days post-operatively

SBS (State Behavioral Scale)

Average Post-operative Total Fentanyl Dose

时间窗: Up to 14 days post-operatively

Length of Non-Invasive Respiratory Support

时间窗: Up to 14 days post-operatively

Average Post-operative Dexmedetomidine Dose

时间窗: Up to 14 days post-operatively

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验