Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)
研究概览
简要总结
Tracheal intubation in the NICU is frequently complicated by severe oxygen desaturation. Apneic oxygenation, a method of applying free flowing oxygen via nasal cannula to apneic patients undergoing intubation, prevents or delays oxygen desaturation during intubation in adults and older children. We propose to enroll patients at two sites (Hospital of the University of Pennsylvania and Children's Hospital of Philadelphia) in a randomized trial in infants undergoing intubation in the NICU to determine if apneic oxygenation, compared with no respiratory support or oxygen during laryngoscopy and intubation attempts (standard care), reduces the magnitude of oxygen desaturation during tracheal intubation encounters.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 365 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants ≥28 weeks corrected gestational age
- •Undergoing intubation in the NICU
- •Pre-medication (including paralytic) administered
排除标准
- •Critical Airway or Airway Anomaly
- •Unstable hemodynamics (i.e. active resuscitation)
- •Unable to achieve SpO2 ≥90% prior to intubation attempt
- •Intubation performed by Non-NICU provider (i.e. anesthesiology or ENT)
- •Unrepaired congenital diagrammatic hernia
- •Tracheal esophageal fistula within 2 weeks of repair
- •Tracheostomy
- •Previous enrollment in the trial
- •Nasal intubation
- •COVID person under investigation (PUI) or COVID positive
- •Cyanotic heart disease
- •Receiving Extracorporeal Membrane Oxygenation support
- •Conjoined twins
研究组 & 干预措施
Apneic Oxygenation
干预措施: Apneic Oxygenation (Procedure)
Standard of Care
干预措施: Standard of Care (Procedure)
结局指标
主要结局
Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)
时间窗: During intubation procedure
Difference between highest SpO2 immediately prior to first intubation attempt and lowest SpO2 during the intubation encounter.
次要结局
- Secondary Clinical Outcome: Severe oxygen desaturation(During intubation procedure)
- Secondary Clinical Outcome: Duration of intubation attempts(During intubation procedure)
- Feasibility Outcome: Protocol deviations(During intubation procedure)
- Feasibility Outcome: Randomization(Through study completion, an average of 18 months.)
- Secondary Clinical Outcome: SpO2<80%(During intubation procedure)
- Secondary Clinical Outcome: Time to SpO2 <80%(During intubation procedure)
- Secondary Clinical Outcome: intubation success(During intubation procedure)
- Secondary Clinical Outcome: Change in pulse rate(During intubation procedure)
- Secondary Clinical Outcome: pCO2(Three hours after intubation)
- Secondary Clinical Outcome: PaO2(Three hours after intubation)
- Feasibility Outcome: Screening(Through study completion, an average of 18 months.)
- Secondary Clinical Outcome: pH(Three hours after intubation)
- Feasibility Outcome: AO fidelity(During the intubation procedure)
- Feasibility Outcome: Recruitment(Through study completion, an average of 18 months.)
- Secondary Clinical Outcome: Number of intubation attempts(During intubation procedure)
研究者
Elizabeth Foglia
Assistant Professor of Pediatrics
University of Pennsylvania