Helmet Continous Positive Airway Pressure (CPAP) Management and Positive End Expiratory Pressure (PEEP) Level Impact on Severe Bronchiolitis Admitted in Pediatric Intensive Care Units (PICUs)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- incidence of pneumothorax following Helmet CPAP treatment
研究概览
简要总结
Binary randomized peep level of Helmet CPAP (1-0). The first patient enrolled will be assign to treatment 1 (10 cmH2O peep level), independently from its BSS. The following patients enrolled will be assign to treatment 0 (5 cmH2O peep level), and consecutively up to 25 patients at least.
- 10 cmH2O peep, 50 L/min gas flow, fraction of inspired oxygen (FiO2) 0.5 on PICU admission (random 1)
- 5 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 0) If clinical and respiratory worsening, reduction of pH or partial oxygen arterial pressure (PaO2)/FiO2 occurs in the following first hour after Helmet CPAP treatment start, patients enrolled will receive endotracheal intubation, full face mask non invasive ventilation or higher peep level treatment (7.5-10 cmH2O) according to clinical evaluation, if necessary.
In investigator's experience, early worsening of severe bronchiolitis in PICU in the first hour of Helmet CPAP treatment with 10 cmH2O peep level leads to endotracheal intubation.
详细描述
INTRODUCTION
Newborns and infants with severe bronchiolitis admitted in PICU (Pediatric Intensive Care Unit) are patients at high risk for invasive mechanical ventilation support. In current literature, there is lack of multicenter, prospective and randomized studies to assess and describe the impact of non invasive ventilation support among severe bronchiolitis admitted in PICU, notwithstanding the actual improvement of non invasive ventilation technique on intubation rate reduction.
Recently, we can find studies on bronchiolitis management in pediatric ward and supported with high flow nasal cannula (HFNC).
The studies on severe bronchiolitis admitted in PICU do not evaluate positive end expiratory pressure (Peep) level applied during Helmet continous positive airway pressure (CPAP) support.
According to Italian PICU Network (TIPNET) data, severe bronchiolitis admitted in PICU intubation rate is close to 10% (report 2010-2016), whatever non invasive ventilation support has been used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 38 Weeks 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of 38 weeks of gestational age up to 18 months old, admitted in PICU for severe bronchiolitis, whose parents have signed written informed consent to enroll the child in the study.
- •Patients with severe bronchiolitis moved from emergency department, pediatric ward, and supported up to 72 hours with HFNC or O2 therapy.
排除标准
- •Severe congenital malformation Inborn congenital error Neonatal or postnatal neurologic disorder Parents refusal to study participation Presence or supposed pneumothorax on chest X-ray or lung ultrasound
结局指标
主要结局
incidence of pneumothorax following Helmet CPAP treatment
时间窗: 72 hours
pneumothorax occurrence
incidence of intubation following Helmet CPAP treatment
时间窗: 7 days
to evaluate intubation rate on severe bronchiolitis admitted in PICU and supported with Helmet CPAP non invasive ventilation with 10 peep level in group 1, and 5 peep level in group 0.
次要结局
- length of stay(days 30)
研究者
Emanuele Rossetti
md
Bambino Gesù Hospital and Research Institute