Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients (NavPed-Inv)
The purpose of this study is to document the prevalence and type of asynchronies incidence during invasive mechanical ventilation in pediatric patients breathing under pressure support.
And to observe the impact of adjusting the expiratory trigger setting on asynchronies, and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).
研究概览
详细说明
Two sessions will be recorded, one in PSV, one with NAVA, delivered in a random order after being sure the infant is calm and comfortable, according to his parents and/or the nurse in charge.
Criteria for initiating invasive ventilation and to start PSV will follow the usual practice guidelines of the unit.
Ventilation parameters in PS will be adjusted by the clinician in charge of the patient, as usual based on clinical observation. Investigators will not interfere with ventilator settings. Ventilation will be applied via an endotracheal tube, uncuffed for the majority (if infant < 5 years), according to commonly applied guidelines in this unit.
One 15 minutes session will be recorded, after being sure the infant is calm and comfortable according to the parents and/or the nurse in charge. Then the clinician in charge of the patient will modify the ETS, first decreasing it of 10% below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 10% above the initial set value, and will be recorded the following 5 minutes after stabilization.
NAVA will be set to deliver initially the same peak pressure (comparable level of assist) than during the initial PS period. Same PEEP will be delivered in both modes. This is possible with a pre-visualization window, allowing adjustments before switching to the NAVA mode. Nava ventilation will be recorded during 20 minutes.
The 2 sessions, Pressure support and Nava, will be recorded consecutively.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Geneva、瑞士、1211
- 招聘中
- University Hospital of Geneva
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接触：
- Laurence Vignaux
- 电话号码：0041223727448
- 邮箱：laurence.vignaux@hcuge.ch
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接触：
- Peter Rimenberger
- 电话号码：00412237 24 730
- 邮箱：peter.rimensberger@hcuge.ch
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首席研究员：
- Peter Rimensberger, MD
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副研究员：
- Laurence Vignaux
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副研究员：
- Thomas Jaecklin, MD
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副研究员：
- Serge Grazioli, MD
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副研究员：
- Lise Piquilloud
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副研究员：
- Philippe Jolliet, Pr
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副研究员：
- Didier Tassaux, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- all consecutive patients from 4 weeks to 12 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical ventilation in pressure support ventilation
Exclusion Criteria:
- Non treated pneumothorax
- Hemodynamic instability
- At least 2 hours following the admission in the PICU in post cardiac surgery
- FiO2 > 0.6
- Poor short term prognosis (defined as a high risk of death in the next seven days)
- contraindication for gastric tube or obtention of a reliable EMGdi signal
- Known esophageal problem (hiatal hernia, esophageal varicosities)
- Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a naso-gastric tube
- Neuromuscular disease
- Patients with a pacemaker
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Pressure support
in this arm, pressure support will be recorded under 3 conditions:
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Ventilation under pressure support
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实验性的：NAVA
Neurally Adjusted ventilatory Assist is a ventilation mode where the ventilator is piloted by the electrical activity of the diaphragm Ventilation is triggered and cycled off by the electrical activity of the diaphragm, the pressure delivered being proportional to this activity.
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Ventilation under NAVA
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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asynchronies
大体时间：12 months
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Asynchronies during mechanical ventilation are the following: Auto triggering, double triggering, late cycling, premature cycling and ineffective effort. all ventilatory parameters are recorded under Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +10% and -10%, 15 min, 5 min and 5 min respectively) and NAVA (1 phase, 20 min). Asynchronies will be determined by measuring each ventilatory cycle of all recordings. |
12 months
|
合作者和调查者
调查人员
- 首席研究员：Peter Rimensberger, MD、University Hospital of Geneva
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- HUG-matped 09-253
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