Cerebral NIRS Profiles During Premedication for Neonatal Intubation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Cerebral desaturation
研究概览
简要总结
Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a 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:
- Cerebral desaturation defined by a rScO2 delta >20% from the baseline value (before premedication).
- Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .
Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral 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
- •Skin lesions or burns of the forehead
研究组 & 干预措施
Atropine + propofol
Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants < 1000g - Renewable once 2.5 mg/kg for infants > 1000G - Possible additional dose of 1 mg/kg
干预措施: atropine+ propofol (Drug)
Atropine + atracurium + sufentanil
Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants < 1000g 0.2 µg/kg for infants > 1000g
干预措施: atropine + atracurium + sufentanil (Drug)
结局指标
主要结局
Cerebral desaturation
时间窗: from 1 minute before to 60 minutes after the start of premedication
rScO2 delta \>20% from the baseline value (before premedication). rScO2 recording measured by INVOS 1500C 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection
FTOE (Fractional Tissue Oxygen Extraction)
时间窗: from 1 minute before to 60 minutes after the start of premedication
Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication. FTOE is calculated from rScO2 and pulse oxymetry (SaO2) with the formula FTOE = SaO2 - rScO2/SaO2. Values will be recorded 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection.
次要结局
未报告次要终点
研究者
Xavier Durrmeyer
MD, PhD
Centre Hospitalier Intercommunal Creteil