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临床试验/NCT01928238
NCT01928238已完成不适用

Physiologic Effects of Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) Versus Noninvasive Pressure Support Ventilation in Patients at Risk for Respiratory Distress Needed Preventive Used of Noninvasive Ventilation After Extubation.

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2012年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
2
主要终点
Inspiratory muscle effort

研究概览

简要总结

The purpose of this study is to compare inspiratory effort, comfort, gas exchange and patient ventilator synchrony during non-invasive neurally adjusted ventilatory assist or pneumatically triggered and cycled-off noninvasive pressure support ventilation (NPSV), in patient at risk of respiratory distress after extubation.

详细描述

Reintubation, which occurs after planned extubation, is a relevant consequence of respiratory failure after extubation. The early use of noninvasive pressure support ventilation averted respiratory failure after extubation in patients at increased risk. However patient tolerance to the technique is a critical factor determining its success. One of the key factors determining tolerance to Non Invasive Ventilation (NIV) is optimal synchrony between the patient's spontaneous breathing activity and the ventilator's settings, known as patient ventilator interaction. Optimal patient-ventilator synchrony during NIV can prove very difficult to achieve due to the presence of leaks, the type of interface which can interfere with various aspects of ventilator function. Patient ventilator synchrony during NPSV can be compromised when using conventional pneumatic triggering, with the ventilator-delivered inspiratory support starting after the patient's inspiratory effort. The switch from inspiration to expiration (cycling-off) should, ideally, coincide with the end of the patient's inspiratory effort. However greater asynchrony at the end of inspiration, with the ventilator cycling off either too early or too late compared to the end of the patient's inspiratory effort can be observed during NPSV. A possible solution is to replace the pneumatic triggering with neural triggering and cycling off using the diaphragm electrical activity (Eadi). Neurally adjusted ventilatory assist (NAVA) uses the electrical activity of the diaphragm to control the timing and pressure of the ventilation delivered. The ventilator is triggered, limited and cycled-off directly by Eadi. The Eadi is measured by a multiple array oesophageal electrode. The array of bipolar electrodes can be mounted on a feeding tube, which is routinely introduced in critically ill patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients intubated for 48 h or more
  • Patients who tolerated a 120-min spontaneous breathing trial after recovery from their acute disease with no signs of respiratory failure
  • Patients at high risk for respiratory after extubation were enrolled if they had at least two of the following risk factors for respiratory failure after extubation:
  • age older than 65 years
  • Chronic obstructive pulmonary disease,
  • heart failure as the cause for intubation
  • An Acute Physiology and Chronic Health Evaluation (APACHE)-II score greater than 12 on the day of extubation.

排除标准

  • Age younger than 18 years
  • Head trauma or surgery
  • Recent gastric or oesophageal surgery
  • Active upper gastrointestinal bleeding
  • Excessive amount of respiratory secretions
  • Poor cooperation
  • Decision to limit life-supporting treatments in the ICU
  • Tracheostomy or other upper airway disorders
  • Lack of collaboration
  • Do not resuscitate order or any decision to limit therapeutic effort in the ICU.

研究组 & 干预措施

Arm 1

Experimental

Patients will have two 20-minute noninvasive periods :

Noninvasive neurally adjusted ventilatory assist (NIV-NAVA) and then Noninvasive pressure support ventilation (NPSV)

干预措施: Noninvasive pressure support ventilation (NPSV) (Device)

Arm 1

Experimental

Patients will have two 20-minute noninvasive periods :

Noninvasive neurally adjusted ventilatory assist (NIV-NAVA) and then Noninvasive pressure support ventilation (NPSV)

干预措施: Noninvasive neurally adjusted ventilatory assist (NIV-NAVA). (Device)

Arm 2

Experimental

Patients will have two 20-minute noninvasive periods :

Noninvasive pressure support ventilation (NPSV) and then Noninvasive neurally adjusted ventilatory assist (NIV-NAVA)

干预措施: Noninvasive neurally adjusted ventilatory assist (NIV-NAVA). (Device)

Arm 2

Experimental

Patients will have two 20-minute noninvasive periods :

Noninvasive pressure support ventilation (NPSV) and then Noninvasive neurally adjusted ventilatory assist (NIV-NAVA)

干预措施: Noninvasive pressure support ventilation (NPSV) (Device)

结局指标

主要结局

Inspiratory muscle effort

时间窗: At inclusion (day 0)

The primary endpoint variable is the inspiratory muscle effort. To estimate the inspiratory effort, we will determine the transdiaphragmatic pressure (Pdi), the transdiaphragmatic pressure time product per breath (PTPdi/b) or per minute (PTPdi/min) and the Electrical Activity of the Diaphragm (EADI)max.

次要结局

  • patient ventilator synchrony(At inclusion (Day 0))
  • gas exchange(At inclusion (Day 0))
  • Patient comfort(At inclusion (Day 0))

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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