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临床试验/NCT04360590
NCT04360590已完成不适用

Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilatory Assist (NAVA) in Difficult to Wean Pediatric ARDS Patients: a Physiologic Crossover Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 12 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
主要终点
asynchrony index

研究概览

简要总结

This study assessed the effects of NAVA versus Pressure Support Ventilation (PSV) on patient-ventilator interaction in pediatric patients with difficult weaning from mechanical ventilation after moderate Pediatric Acute Respiratory Distress Syndrome (PARDS).

详细描述

12 pediatric patients, admitted in Pediatric Intensive Care Unit (PICU) with moderate PARDS and who failed up to 3 SBTs in less than 7 days, were enrolled in this study. These patients underwent three studies conditions, lasting 1 hour each: Pressure support ventilation 1, Neurally adjusted ventilatory assist and Pressure support ventilation 2.

During each trial were recorded the patient tracings of flow, airway pressure and electrical activity of diaphragm for the patient-ventilator interaction analysis.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

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

  • diagnosis of moderate PARDS
  • 3 spontaneous breathing trials failed in less than 7 days

排除标准

  • hemodynamic instability
  • severe respiratory instability
  • contraindication to nasogastric tube exchange
  • increase in intracranial pressure
  • palliative care for end-stage oncologic disease
  • neuromuscular disease
  • lesions of medulla

结局指标

主要结局

asynchrony index

时间窗: three years

in each study condition, the asynchrony index was measured. The asynchrnony index value grater than 10% is an indicator of worsening patient-ventilator interaction. the Asynchrony Index is the ratio between the number of asynchronous events and the total respiratory rate, expressed as percentage

次要结局

  • patient-ventilator interaction(three years)
  • interaction(three years)
  • synchrony between patient and mechanical ventilator(three years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SPINAZZOLA GIORGIA

Medical doctor, specialist in Anesthesia and Intensive Care Medicine

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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