Pilot Study of Recurrent Laryngeal Nerve Monitoring During Neonatal Aortic Arch Repair
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Vocal cord EMG - Burst frequency (Hz)
研究概览
简要总结
Almost half of newborns undergoing surgery to repair narrowing or interruption of the aortic arch will suffer injury to the recurrent laryngeal nerve. This causes a weak voice and can lead to problems with feeding including aspiration of milk feed after the surgery. As these children can have a vulnerable circulation, aspiration events can reduce survival and poor weight gain has been shown to correlate with poorer outcomes after surgery.
In other types of surgery in the neck, monitors can be used to alert the surgeon to when injury is occurring to the recurrent nerve. To date, this type of monitoring has not been possible in newborns. This study aims to investigate if this type of monitoring is feasible in newborns undergoing aortic arch repair, to prevent recurrent nerve injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only patients with parents/ carers able to give informed consent to participation in the trial will be included. • Male and female patients will be included
- •Only Neonates (babies less than 28 days of age) will be included in the study.
- •Only patients undergoing repair of the aortic arch via median sternotomy will be included in the study
排除标准
- •Patients with severe abnormalities of the airway, such that they are unlikely to be extubated within 7 days of the aortic arch repair surgery will be excluded from participation, as assessment of vocal cord function will be difficult/ impossible in such patients.
- •Patients with parents/ carers who are unable to give informed consent to participation in the trial will be excluded from participation.
结局指标
主要结局
Vocal cord EMG - Burst frequency (Hz)
时间窗: Intra-operative (1 hour)
Feasibility of performing vocal cord EMG during neonatal arch repair
Vocal cord EMG - Signal to noise ratio (mV)
时间窗: Intra-operative (1 hour)
Feasibility of performing vocal cord EMG during neonatal arch repair
Vocal cord EMG - Burst amplitude (mV)
时间窗: Intra-operative (1 hour)
Feasibility of performing vocal cord EMG during neonatal arch repair
Vocal cord EMG - Burst duration (ms)
时间窗: Intra-operative (1 hour)
Feasibility of performing vocal cord EMG during neonatal arch repair
Vocal cord EMG - Interburst interval (ms)
时间窗: Intra-operative (1 hour)
Feasibility of performing vocal cord EMG during neonatal arch repair
Correlation of Vocal cord EMG with post-operative palsy
时间窗: Post extubation / 1 week post-operatively
Vocal cord ultrasound
次要结局
- Neuromuscular blockade(Intra-operative (1 hour))