Recurrent Nerve Monitoring During Aortic Arch Repair (PREMAR)

Birmingham Women's and Children's NHS Foundation Trust

Status

Unknown

Conditions

Aortic Arch Hypoplasia

Recurrent Laryngeal Nerve Injuries

Treatments

Diagnostic Test: Electromyography

Study type

Interventional

Funder types

Other

Identifiers

NCT04994964

20/BC/CARDIO/NO/444

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

Under 28 days old

Volunteers

No Healthy Volunteers

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.