NCT04994964

Recurrent Nerve Monitoring During Aortic Arch Repair

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Birmingham Women's and Children's NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Recurrent Laryngeal Nerve Injuries
• Aortic Arch Hypoplasia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Electromyography	Needle vocal cord electromyography using Medtronic NIM monitor

Timeline

• Start date: 2021-03-23
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2021-08-06
• Last updated: 2021-08-06

Locations

1 site across 1 country: United Kingdom