Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support in Pediatric Acute Respiratory Failure - Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Avoiding endotracheal intubation using non-invasive ventilation
研究概览
简要总结
This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.
详细描述
This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.
Every PICU will have to include 3 patients in the Pilot study before starting the clinical trial, which means that the pilot study will involve a maximum of 60 patients.
Should the Pilot study reveal deficiencies in the NiNAVAped design, the protocol would be improved accordingly.
There will be a specific consent document during the Pilot study. The Pilot study will be published in a scientific journal.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: > 1 month age to 18 years
- •Moderate/severe Pediatric Acute Respiratory failure of any origin evaluated after a period of respiratory stabilization (aspiration of secretions, physiotherapy, oxygen and nebulized therapy) when the attending pediatric intensive care physician believes that the patient is likely to require endotracheal intubation (ETI).
- •Non intubated
- •Admitted to the PICU
- •Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2)
排除标准
- •Patients younger than 1 month or older than 18 year
- •Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion
- •Facial trauma/burns
- •Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding
- •Fixed obstruction of the upper airway
- •Inability to protect airway
- •Life threatening hypoxemia defined as SpaO2 <90% with FiO2 > 0.8 on hi-flow oxygen.
- •Hemodynamic instability: refractory at volume expansion >60 ml/kg and dopamine >10 mcg/kg/min
- •Impaired consciousness defined as Glasgow coma scale <
- •Bowel obstruction.
- •Untreated pneumothorax.
- •Poor short term prognosis (high risk of death in the next 3 months)
- •Known esophageal problem (hiatal hernia, esophageal varicosities)
- •Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a NG tube.
- •Neuromuscular disease
- •Cough or gag reflex impairment.
- •Cyanotic congenital heart disease.
- •Complete absence of cooperation
- •This patient has been included (randomized) previously in the study
结局指标
主要结局
Avoiding endotracheal intubation using non-invasive ventilation
时间窗: During non invasive ventilation, an average of 2-3 days.
The primary endpoint of this study is avoiding endotracheal intubation (ETI) (and conventional mechanical ventilation (MV)) using non-invasive ventilation (NIV). It is defined as no need for ETI (and MV) for at least 48h after the withdrawal of NIV.
次要结局
- Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV(During mechanical ventilation after NIV)
- Length (days) of PICU stay after NIV(After NIV)
- Length (days) hospital stay after NIV(After NIV)
研究者
Ignacio Galicia
Dr
Hospital Universitario La Paz