Recurrent Nerve Monitoring During Aortic Arch Repair

Birmingham Women's and Children's NHS Foundation Trust20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Recurrent Laryngeal Nerve Injuries Aortic Arch Hypoplasia

Interventions

Eligibility

Sex: ALLMin age: 0 DaysMax age: 28 Days

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Vocal cord EMG - Burst amplitude (mV)

Feasibility of performing vocal cord EMG during neonatal arch repair

Time frame: Intra-operative (1 hour)

Vocal cord EMG - Burst duration (ms)

Feasibility of performing vocal cord EMG during neonatal arch repair

Time frame: Intra-operative (1 hour)

Vocal cord EMG - Burst frequency (Hz)

Feasibility of performing vocal cord EMG during neonatal arch repair

Time frame: Intra-operative (1 hour)

Vocal cord EMG - Interburst interval (ms)

Feasibility of performing vocal cord EMG during neonatal arch repair

Time frame: Intra-operative (1 hour)

Vocal cord EMG - Signal to noise ratio (mV)

Feasibility of performing vocal cord EMG during neonatal arch repair

Time frame: Intra-operative (1 hour)

Correlation of Vocal cord EMG with post-operative palsy

Vocal cord ultrasound

Time frame: Post extubation / 1 week post-operatively

Secondary Outcomes

Neuromuscular blockade

Influence of timing of neuromuscular blockade on EMG signal

Time frame: Intra-operative (1 hour)

Recurrent Nerve Monitoring During Aortic Arch Repair

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts