Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Heart rate less than 80 BPM and oxygen saturation less than 80%
研究概览
简要总结
The purpose of this study is to compare heart rate in infants who receive atropine as a part of their medication before intubation to those who do not.
To be able to find out , we need to divided babies into 2 groups;
group 1 : receives atropine + sedation + muscle relaxant group 2 : receives water or saline ( placebo group) + sedation + muscle relaxant
Then we need to compare heart rate during intubation and duration of intubation between the 2 groups.
详细描述
We hypothesize that premedication for intubation with fentanyl and succinylcholine alone will maintain equal stability of heart rate and oxygen saturation without a prolongation of time to completion of intubation when compared to a protocol using atropine, fentanyl and succinylcholine.
In order to answer this question we plan to undertake a prospective randomized double blinded control trial of use of atropine as an adjunct for elective intubation of infants less than 46 weeks postmenstrual age.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any infant (preterm and term) up to 46 weeks corrected age requiring (nonemergent) intubation.
- •IV access is obtained
- •Informed parental consent
排除标准
- •Emergent intubation or need for resuscitation
- •Congenital cyanotic heart disease
- •Obvious airway abnormalities
- •History of myopathy or family history of malignant hyperthermia or known history of phosphocholinesterase deficiency
研究组 & 干预措施
Atropine, fentanyl and succinylcholine
20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.
干预措施: atropine (Drug)
placebo, fentanyl and succinylcholine
an equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.
干预措施: Placebo (Drug)
结局指标
主要结局
Heart rate less than 80 BPM and oxygen saturation less than 80%
时间窗: 5-6 minutes
Heart rate and transcutaneous oxygen saturation will be monitored continuously during the procedure and data will be recorded at 3 stages; 1. 2 minutes prior to intubation (after atropine or placebo dose) 2. during intubation 3. 2 minutes after intubation (once ETT secured to face)
次要结局
- Duration of intubation attempts(1-2 minutes)
- Number of intubation attempts(5-6 minutes)
- Lowest heart rate after premedication(5-6 minutes)
- Lowest oxygen saturation after premedication(5-6 minutes)
- Heart rate < 100 BPM(5-6 minutes)
- Oxygen saturation < 85%(5-6 minutes)