Recurrent Nerve Monitoring During Aortic Arch Repair
Research type
Research Study
Full title
Pilot Study of Recurrent Laryngeal Nerve Monitoring During Neonatal Aortic Arch Repair
IRAS ID
266850
Contact name
Sarah Hadfield
Contact email
Sponsor organisation
Birmingham Women's and Children's NHS FT
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
About 1 in 100,000 children are born with a narrowed or interrupted aorta, the large blood vessel that takes blood from the heart to the rest of the body. These children require major surgery during the first days or weeks of life to repair the narrowing, or they will not survive. About 370 of these operations are carried out in the United Kingdom every year. The Recurrent Laryngeal nerve is a nerve that arises in the neck, wraps around the aorta, and then ascends back up the throat to supply the vocal cord and larynx. Due to its position, this nerve is at great risk of injury during surgery to the aortic arch. Injury to the Recurrent nerve results in a weak or hoarse voice, and difficulties in feeding. Almost half of newborns requiring aortic arch repair will demonstrate these signs of injury after the operation.
In other forms of neck surgery, including removal of the thyroid gland, nerve monitors are used routinely to detect and prevent injury to the recurrent nerve during the operation. Unfortunately, these monitors can only be used in large children or adults, because it requires a large tube with electrodes to be placed in the airway. New evidence suggests that the same type of monitor could be used to monitor for recurrent nerve injury in newborns undergoing aortic arch surgery by placing tiny wire electrodes next to the voicebox during the operation. It is the aim of this study to investigate whether this method could be used to monitor for injury to the recurrent nerve in newborns undergoing aortic arch repair surgery to prevent injury to the nerve. The study will involve testing this method of nerve monitoring in 20 newborn babies undergoing aortic arch repair, and correlating the monitoring with post-operative vocal cord function.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
20/WM/0298
Date of REC Opinion
24 Nov 2020
REC opinion
Favourable Opinion