Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Work of breathing
研究概览
简要总结
Acute viral bronchiolitis is the first cause of respiratory distress in infant. Airway inflammation increases the respiratory system resistances and dynamic hyperinflation. This leads to an increase in the work of breathing. In Chronic obstructive pulmonary disease patients as in neonates, prone position (PP) improves lung function and decreases the end expiratory lung volume. The investigators hypothesized that in infants with severe bronchiolitis, prone position reduces the intrinsic Positive End Expiratory Pressure (PEEPi) and the work of breathing (WOB). The investigator designed a prospective randomized crossover study with 16 infants younger than six months who need ventilatory support by nasal continuous positive airway pressure (nCPAP) for severe acute viral bronchiolitis. Work of breathing (product time pressure) and PEEPi will be estimated using an esophageal pressure probe in prone and supine position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant < 6 months
- •Admitted in the pediatric intensive care unit of the Femme-Mère-Enfant hospital, Hospices Civils de Lyon, France
- •With severe acute viral bronchiolitis requiring ventilatory support (mWCAS > 4 and/or and or FiO2> 40% and/or hypercapnic acidosis (pH<7.30 and/or pCO2>8 kPa))
- •Signed informed consent by the two parents or the owner of parental authority
排除标准
- •Chronic respiratory, neuromuscular, ENT or cardiac disease
- •Contraindication for placement of esophageal probe (esophageal surgery, varices, …)
- •Children requiring invasive ventilation (more than 3 significant apneas in 1 hour, decreased consciousness, …)
- •Children not affiliated to a social security scheme
研究组 & 干预措施
PRONE-Supine
We test the hypothesis that in infants with severe bronchiolitis, prone position reduces the work of breathing (WOB) and the intrinsic Positive End Expiratory Pressure (PEEP).
干预措施: Prone then supine position (Procedure)
SUPINE - Prone
We test the hypothesis that in infants with severe bronchiolitis, prone position reduces the work of breathing (WOB) and the intrinsic Positive End Expiratory Pressure (PEEP).
干预措施: Supine then Prone position (Procedure)
结局指标
主要结局
Work of breathing
时间窗: 60 min
The primary outcome is the work of breathing (WOB) estimated by the mean on 100 breaths of the esophageal and trans-diaphragmatic Pressure-Time Product (PTP) at the end of the first hour.
次要结局
- EDIN score (neonatal pain and discomfort scale)(60 min)
- Heart rate(60 min)
- SPO2(60 min)
- Intrinsic PEEP(60 min)
- Respiratory rate(60 min)
- Inspiratory:Expiratory Time Ratio(60 min)
- Transcutaneous CO2(60 min)