Recurrent Nerve Monitoring During Aortic Arch Repair
United Kingdom20 participantsStarted 2021-03-23
Plain-language 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.
Who can participate
Age range
0 Days – 28 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vocal cord EMG - Burst amplitude (mV)
Timeframe: Intra-operative (1 hour)
2
Vocal cord EMG - Burst duration (ms)
Timeframe: Intra-operative (1 hour)
3
Vocal cord EMG - Burst frequency (Hz)
Timeframe: Intra-operative (1 hour)
4
Vocal cord EMG - Interburst interval (ms)
Timeframe: Intra-operative (1 hour)
5
Vocal cord EMG - Signal to noise ratio (mV)
Timeframe: Intra-operative (1 hour)
6
Correlation of Vocal cord EMG with post-operative palsy
Timeframe: Post extubation / 1 week post-operatively
Trial details
NCT IDNCT04994964
SponsorBirmingham Women's and Children's NHS Foundation Trust