Double Blind Randomized Controlled Trial Comparing "Atropine+Propofol" Versus "Atropine+Atracurium+Sufentanil" as a Premedication Prior to Semi-urgent or Elective Endotracheal Intubation of Term and Preterm Newborns
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 6
- 主要终点
- Number of Patients With Prolonged Desaturation
研究概览
简要总结
Multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.
Primary outcome: pulse oxymetry value < 80% for more than 60 seconds. Secondary outcomes: number of attempts, duration of the procedure, changes in physiologic parameters, short- and long-term neurodevelopmental outcome.
Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" will significantly reduce the frequency of severe hypoxemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Corrected age < 45 weeks of gestational age
- •Currently hospitalized in a neonatal intensive care unit
- •Requiring semi-urgent or elective intubation
- •Equipped with a reliable and permeable IV line
- •Parental consent
排除标准
- •Lack of parental consent
- •Parental refusal
- •Sedative or anesthetic treatment in the previous 24 hours
- •Hemodynamic compromise defined as mean blood pressure< corrected GA and/or refill time > 3 seconds
- •Upper airway malformation
- •Life-threatening situation requiring immediate intubation
- •Inclusion in another trial not permitting any other participation
- •Impossibility to establish venous access
- •Any contra-indication to any experimental drug
研究组 & 干预措施
Atropine + Propofol
干预措施: atropine+ propofol (Drug)
Atropine + atracurium + sufentanil
干预措施: atropine + atracurium + sufentanil (Drug)
结局指标
主要结局
Number of Patients With Prolonged Desaturation
时间窗: During intubation procedure, expected duration 1 to 15 minutes
Pulse oxymetry value measured by Masimo technology below 80% for 60 seconds or more. Duration of intubation is defined by the time between first laryngoscope insertion and last laryngoscope removal after successful intubation. Successful intubation is defined by clear bilateral breath sounds, increasing heart rate and saturation (if previously low) and appropriate flow curves on the ventilator.
次要结局
- Number of Intubation Attempts(During intubation procedure, expected duration 1 to 15 minutes)
- Duration of Intubation Procedure(Expected duration 1 to 15 minutes)
- Heart Rate(from 1 minute before to 60 minutes after the start of premedication)
- Short Term Neurological Outcome: Worsening of Head Ultrasound(Within 7 days after inclusion)
- Number of Patients Surviving Without Ages and Stages Questionnaire Score Below Threshold at Age 2(At 2 years corrected age)
- Pulse Oxymetry(from 1 minute before to 60 minutes after the start of premedication)
- Mean Blood Pressure(from 1 minute before to 60 minutes after the start of premedication)
- Transcutaneous PCO2 (TcPCO2) Measurement(from 1 minute before to 60 minutes after the start of premedication)
研究者
Xavier Durrmeyer
Principal Investigator
Centre Hospitalier Intercommunal Creteil