aPneic oxygEnation duriNg emerGent intUbation of crItically Ill childreN: a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 7
- 主要终点
- Number of patients with desaturation < 85 percent during intubation
研究概览
简要总结
This study compares the actual standard of care of intubation in Swiss pediatric intensive care units vs the use of apneic oxygenation using either high flow or low flow oxygen to prevent hypoxemia and to prolong apnea time during intubation of critically ill children, with the final aim to improve airway management safety at PICUs. Primary study objective: To demonstrate that airway management supported by oxygen supplementation (either HFNC or low flow oxygen) can prevent significant desaturation (SpO2 > 85%) among patients in pediatric intensive care units (PICU) and neonatal intensive care units (NICU).
详细描述
Randomized controlled multicenter trial in Swiss pediatric ICUs with randomization to 3 groups: 1) standard of care with conventional preoxygenation with bag-mask ventilation vs 2) conventional preoxygenation with bag-mask ventilation and apneic oxygenation with low-flow Oxygen fraction of inspired oxygen (FiO2) 100% 0.2 L/kg/min vs 3) conventional preoxygenation with bag-mask ventilation and apneic oxygenation with THRIVE FiO2 100% 2L/kg/min.
Eligible children meeting the inclusions criteria will be prepared for oral intubation according to the standard operating procedure (SOP) of the respective NICU/PICU. SpO2, heart rate, invasive or non-invasive blood pressure values shall be recorded continuously (for invasive continuously and for non-invasive intermittently every 2 minutes and 30 seconds), once the decision to intubate has been made. The sealed envelope for randomization will then be opened. All patients must be intubated orally. The induction will be performed according to the clinical needs of the child. All children will be intubated using the C-MAC videolaryngoscope with a Miller or Macintosh-blades (Karl Storz, Tuttlingen, Germany) age adopted.
Before oral intubation preoxygenation is performed for 2 minutes with a facemask usually used at the study site with an FiO2 of 1.0 and flow rates of 6-10L/min in all groups. After induction, all patients will be paralyzed with an age appropriate dose of muscle relaxant to ensure apnoea. The dose of the neuromuscular blocking agent and the depth of the anesthesia shall be adjusted according to clinical parameters such as absent reactions to jaw thrust and normocardia. In all groups, after induction, bag-mask ventilation with 100% oxygen and flow rates of 6-10 Lmin-1 will be continued for about 45-60 seconds until apnea sets in. Thereafter bag-mask ventilation will be stopped and one of the three study interventions will be applied according to randomization:
Control group: When apnea sets in, deep laryngoscopy and endotracheal oral intubation are performed without apneic oxygenation.
Intervention group - high flow: Prior to the introduction of the laryngoscope, apneic oxygenation is commenced with a high-flow nasal cannula flow rate of 2L/kg/min using OptiFlow system at an FiO2 of 1.0. After starting THRIVE laryngoscopy and tracheal oral intubation is performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 37 Weeks 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients requiring intubation in the pediatric intensive care unit
- •Aged from 37 weeks corrected gestational age to 6 years
- •Legal guardians providing written informed consent before the intervention or delayed consent in the event that emergency intubation is required
排除标准
- •Patients with known or suspected difficult/airways
- •Congenital heart disease mandating FiO2 < 1.0, warranting inhalational induction, requiring ongoing CPR or advanced life support due to respiratory arrest
- •Preterm age < 37 0/7 weeks
- •Patients who cannot be intubated orally
- •Respiratory insufficiency with an SpO2 saturation < 90 % after 2 min of preoxygenation with FiO2 = 1.0
- •Newborns requiring surfactant within the first 3 days of life
- •Document stating intent to reject participation in research projects or refusal of intubation or refusal of resuscitation measures
结局指标
主要结局
Number of patients with desaturation < 85 percent during intubation
时间窗: 15 minutes
To demonstrate that airway management supported by oxygen supplementation (either HFNC or low flow oxygen) can prevent significant desaturation (SpO2 \> 85%) among patients in pediatric intensive care units (PICU) and neonatal intensive care units (NICU).
次要结局
- Duration of desaturation < 85 percent(15 minutes)
- First attempt success rate(15 minutes)
- Number of patients with desaturation low-flow oxygen vs. HFNC(15 minutes)
- Number of attempts(15 minutes)
- Time required for intubation(5 minutes)
- Level of desaturation < 85 percent(15 minutes)