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临床试验/NCT02050217
NCT02050217Unknown3 期

Patient Ventilator Interaction During Non-invasive Ventilation Delivered With Neurally Adjusted Ventilatory Assist (NAVA-NIV) in Infants Delivered by Helmet: a Pilot Short Term Physiological Study

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
3 期
入组人数
10
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), 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. Among different interfaces, the pediatric helmet is better tolerated than facial or nasal mask, thus requiring less sedation and allowing more prolonged ventilatory assistance (5-6).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) with helmet.

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 (1). 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 (2). 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 (1,3,4). 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 (3). With these conditions, NAVA was able to unload the respiratory muscles and preserve gas exchange, while maintaining synchrony to respiratory demand. Data from medical literature from our group demonstrate that the pediatric helmet was better tolerated than facial mask , required less sedation an allowed more prolonged ventilatory assistance due to better tolerance (5-6). 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). Equipment. NAVA and conventional PSV is provided by the Servo-I ventilator (Maquet Critical Care, Solna, Sweden). Electrical activity of the diaphragm (EAdi) is obtained using an array of nine miniaturized electrodes (spaced 6 mm apart) mounted on a conventional (5.5F) feeding tube (Maquet Critical Care AB, Solna, Sweden; Neurovent Research Inc, Toronto, Canada), and positioned in the lower esophagus at the level of the diaphragm. Confirmation of appropriate placement is achieved by viewing the online electrical displays from the catheter. The presence of a good quality EAdi trace with p waves displayed by the central electrodes indicates optimal positioning, with the array spanning the diaphragm equally in both caudal and cranial directions. A pediatric helmet is used as interface between the patient and the ventilator. Tidal volume , airway pressure and flow trace are recorded with the Servo I NAVA Tracker acquisition system.

Experimental protocol. Enrolled patients, after a stabilization period with oxygen therapy and standard medical treatment (antibiotics, steroids, Inhaled beta 2 agonists), receive two 60-minutes ventilatory trials delivered by pediatric helmet.

After a baseline trial on PSV conventional , children are allocated to receive 1 trial NAVA NIV and 1 trial PSV conventional. The sequence of the two ventilatory trials are randomized according to sealed opaque envelops.

Ventilatory trials are as follows:

  1. NAVA-NIV
  2. PSV conventional . The first 15 mins of each period are considered as a wash out period and patients are carefully observed for any reactions or problems occurring for the technique. After the first 15 mins period, data recording for the study are started.

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 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants aging > 1 month and < 2 years
  • 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
  • Reduction in airway protection
  • Contraindication to insert the nasogastric catheter
  • Heart and/or lung transplant
  • Increase in PIC
  • Refusal of the parents or legal guardian

结局指标

主要结局

Asynchrony Index

时间窗: 60 minutes trial

次要结局

  • Arterial Blood Gases(end of 60 minutes ventilation trial)

研究者

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

Prof. Pier Mannuccio Mannucci

Professor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

研究点 (2)

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