The IntubAID Study - Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Successful nasal intubation at the first intubation attempt without physiological instability
研究概览
简要总结
The goal of this study is to perform a quality control assessment of our local intubation protocol in any newborn infant requiring endotracheal intubation in the delivery room or neonatal intensive care unit at the Department of Neonatology of the University Hospital Zurich. The primary aims are:
- Successful nasal intubation at the first attempt without physiological instability.
- Comparison of infants with successful intubation at the first attempt without physiological instability to the infants in the SHINE-Trial in Australia.
Participants will be intubated according to our standard intubation procedure using non-invasive ventilation (NIV) delivered through a nasopharyngeal tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any neonate at the Department of Neonatology of the University Hospital Zurich undergoing endotracheal intubation in the delivery room or neonatal intensive care unit.
排除标准
- •Requirement for immediate endotracheal intubation as determined by the treating clinician, without time for potential application of NIPPV, e.g. active cardiopulmonary resuscitation.
- •Contraindication to NIPPV use (e.g. congenital diaphragmatic hernia, abdominal wall defects).
- •Oral intubation planned.
- •Denial of parental consent and/or inability of the parents to understand the study procedures due to cognitive or linguistic reasons.
- •Withdrawal at the discretion of the intubating clinician if he / she feels the study is interfering with a safe and optimal treatment of the patient.
结局指标
主要结局
Successful nasal intubation at the first intubation attempt without physiological instability
时间窗: first intubation attempt
Number of successful intubations at the first intubation attempt. Physiological instability is defined as the absolute decrease in SpO2 of \>20% from baseline and/or bradycardia with a heart rate of \<100 bpm for any duration during the first intubation attempt. Baseline is defined as the time immediately before removal of face mask or prong for placement of the nasopharyngeal tube. The intubation starts and ends with the insertion and removal of the laryngoscope blade beyond the infant's lip.
次要结局
- Time to desaturation during first intubation attempt(first intubation attempt)
- Duration of desaturation during first intubation attempt(first intubation attempt)
- Duration of bradycardia during first intubation attempt(first intubation attempt)
- Number of intubation attempts(overall intubation procedure)
- Incidence of epinephrine administration(Within one hour of first intubation attempt)
- Incidence of pneumothorax requiring drainage(Within 24 hours of first intubation attempt)
- Incidence of desaturation(first intubation attempt)
- Peripheral oxygen saturation(first intubation attempt)
- Heart rate(first intubation attempt)
- Time to bradycardia during first intubation attempt(first intubation attempt)
- Duration of intubation attempt(s)(overall intubation procedure)
- Incidence of death(Within 24 hours of first intubation attempt)
- Incidence of bradycardia(first intubation attempt)
- Number of disconnections from ventilator circuit(overall intubation procedure)
- Incidence of cardiac compressions(Within one hour of first intubation attempt)