跳至主要内容
临床试验/NCT03697863
NCT03697863Unknown不适用

Noninvasive Neurally Adjusted Ventilatory Assist Versus Flow-triggered Noninvasive Pressure Support in Pediatric Acute Respiratory Failure: an Observational Study

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Intubation rate

研究概览

简要总结

Acute Hypoxemic Respiratory Failure (AHRF) is a leading cause of admission in Pediatric Intensive Care Unit (PICU). Traditional treatment includes endotracheal intubation and mechanical ventilation, that are invasive and not free from risks. Recent experiences from pediatric studies showed that Non-Invasive Pressure Support Ventilation (NIV-PS) has been associated with lower intubation rate, adverse events and mortality compared to mechanical ventilation delivered by an endotracheal tube. Nonetheless, in pediatric ARF, the application of a well-synchronized NIV-PS is technically challenging due to the presence of leaks and the age-specific characteristics of pediatric respiratory pattern (high respiratory rate, short inspiratory/expiratory time and weak inspiratory effort). Consequently, NIV-PS often results in difficult patient-ventilator interaction, with a failure rate up to 43% . Neurally Adjusted Ventilatory Assist (NAVA) is a new form of ventilatory assistance wherein the ventilator applies positive pressure throughout inspiration synchronously and proportionally to the Electrical Diaphragm activity (Edi). Thus, NAVA is not influenced by large leaks around uncuffed endotracheal tubes or noninvasive interfaces. Studies in intubated children found that NAVA improved interaction by reducing asynchronies and optimizing ventilator cycling.Two recent studies showed that the application of Non-Invasive NAVA (NIV-NAVA) in children with ARF is feasible and may reduce asynchronies as compared to NIV-PS.

More recently, in a recent RCT of our group, we demonstrated that NIV NAVA in children was associated with lower asynchronies, longer synchronization time between patient and ventilator at lower peak and mean airway pressure.

However no data are published to address the question if the better synchronization between patients and ventilator obtained with NIV NAVA could lead to a reduction in intubation rate and PICU outcomes.

To address this question, we designed an observational retrospective study aiming to define if early delivered NIV NAVA could reduce intubation rate if compared with traditionally flow-cycled NIV PS in hypoxemic children admitted to PICU.

详细描述

End point

Primary end point is the intubation rate between groups. Secondary end points include: days on mechanical ventilation, number o invasive devices, nosocomial infections, PICU and Hospital length of stay and survival at 2-6 months.

Study design

Single center retrospective study

Sample size calculation and statistical analysis

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Emergency need for intubation Glasgow Coma Scale <12 pH<7.25 Cough reflex impairment Upper-airway obstruction Hemodynamic instability (need for vasopressor or inotropes) Evidence of pneumothorax on lung echo or chest x ray Esophageal surgery, neuromuscular, mitochondrial, metabolic or chromosomal diseases with baby hypotonia and lesions of medulla.
  • Were excluded even patients whose parents denied the consent to manage personal data at admission and patient lacking data on medical charts report

结局指标

主要结局

Intubation rate

时间窗: First 48 hours from PICU admission

Frequency of intubation between the two treatment

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 (1)

Loading locations...

相似试验