Recurrent Nerve Monitoring During Aortic Arch Repair

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Recurrent Laryngeal Nerve Monitoring During Neonatal Aortic Arch Repair

Conditions
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Recurrent Laryngeal Nerve Injuries, Aortic Arch Hypoplasia

Intervention / Treatment
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* Diagnostic Test: Electromyography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Electromyography|Needle vocal cord electromyography using Medtronic NIM monitor|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vocal cord EMG - Burst amplitude (mV) | Feasibility of performing vocal cord EMG during neonatal arch repair | Intra-operative (1 hour) | 
| Vocal cord EMG - Burst duration (ms) | Feasibility of performing vocal cord EMG during neonatal arch repair | Intra-operative (1 hour) | 
| Vocal cord EMG - Burst frequency (Hz) | Feasibility of performing vocal cord EMG during neonatal arch repair | Intra-operative (1 hour) | 
| Vocal cord EMG - Interburst interval (ms) | Feasibility of performing vocal cord EMG during neonatal arch repair | Intra-operative (1 hour) | 
| Vocal cord EMG - Signal to noise ratio (mV) | Feasibility of performing vocal cord EMG during neonatal arch repair | Intra-operative (1 hour) | 
| Correlation of Vocal cord EMG with post-operative palsy | Vocal cord ultrasound | Post extubation / 1 week post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuromuscular blockade | Influence of timing of neuromuscular blockade on EMG signal | Intra-operative (1 hour) |