Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- asynchronies
研究概览
简要总结
The purpose of this study is
- to document the prevalence and type of asynchronies incidence during non-invasive mechanical ventilation in pediatric patients breathing under pressure support.
- to observe the impact of adjusting the expiratory trigger setting on asynchronies during pressure support
- and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).
详细描述
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 non-invasive ventilation will follow the usual practice guidelines of the unit.
Ventilation parameters in Non-invasive-Pressure Support 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 15% (absolute value)below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 15% (absolute value)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 non-invasive-ventilation will be recorded during 20 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 4 Weeks 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all consecutive patients from 4 weeks to 5 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical non-invasive ventilation in pressure support ventilation
排除标准
- •Non treated pneumothorax
- •Hemodynamic instability
- •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
研究组 & 干预措施
Non-Invasive Pressure support
in this arm, non-invasive pressure support will be recorded under 3 conditions:
with the initial Expiratory Trigger Setting (ETS) with ETS +15% with ETS -15%
干预措施: Non-invasive Ventilation under Pressure Support (Other)
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.
The proportion named gain is chosen to obtain under NAVA the same peak pressure than during Presure Support
干预措施: Non-Invasive ventilation under NAVA (Other)
结局指标
主要结局
asynchronies
时间窗: 12 months
Asynchronies during mechanical ventilation are the following: Auto triggering, double triggering, late cycling, premature cycling and ineffective effort. all ventilatory parameters are recorded under non-invasive-Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +15% and -15%, 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.
次要结局
未报告次要终点
研究者
Peter C. Rimensberger
Dr Peter Romensberger
University Hospital, Geneva