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临床试验/NCT02043990
NCT02043990Unknown不适用

Patient Ventilator Interaction During Non-invasive Ventilation Delivered With Neurally Adjusted Ventilatory Assist (NAVA-NIV) in Infants

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
2
主要终点
Asynchrony Index

研究概览

简要总结

Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. To test the hypothesis that NAVA could provide better patient-ventilator synchrony during NIV delivered by nasal-facial mask as compared to conventional flow-triggered PSV in infants with Acute Respiratory Failure.

详细描述

Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the Electrical Activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. Because ventilator functioning and cycling are under control of the patient's respiratory drive and rhythm, NAVA has the potential to enhance patient-ventilator interaction ensuring synchrony and minimizing the risk of over-assistance. A high incidence of asynchrony events has been demonstrated to have a significant clinical impact by favouring weaning failure and longer duration of mechanical ventilation.

NAVA has been implemented safely in animals, in healthy volunteers and in critically ill adults and has been shown to improve patient-ventilator synchrony, to limit excessive airway pressure and tidal volume, and to unload the respiratory muscles in tracheally intubated patients.

Moreover NAVA was found to be effective in delivering non-invasive ventilation (NIV) even when the interface was excessively leaky (75% leak) with reduced positive end-expiratory pressure. With these conditions, NAVA was able to unload the respiratory muscles and preserve gas exchange, while maintaining synchrony to respiratory demand. To date, no data exist on the use of NAVA in infants during noninvasive ventilation. The aim of this physiological study is to compare patient-ventilator interaction in infants receiving NIV by NAVA and Pressure Support Ventilation (PSV).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Month 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Infants aging > 1 month and < 2 yrs
  • ARF (PaO2/FiO2 < 300 mmHg)
  • Accessory muscle recruitment
  • Respiratory Rate more than 2 SD related to age
  • Intact neuromuscular pathway to the diaphragm

排除标准

  • Hemodynamic instability
  • Facial Surgery
  • Reduction in airway protection
  • Contraindication to insert the nasogastric catheter
  • Heart and lung transplant
  • Increase in PIC
  • Refusal of the parents or legal guardian
  • Enrolment in other research protocols

结局指标

主要结局

Asynchrony Index

时间窗: 60 minutes of each ventilatory trial, PSV or NAVA

次要结局

  • Arterial blood gases(End of each ventilatory trial)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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