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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electromyography | Diagnostic Test | Needle vocal cord electromyography using Medtronic NIM monitor |
| Measure | Description | Time Frame |
|---|---|---|
| Vocal cord EMG - Burst amplitude (mV) | Feasibility of performing vocal cord EMG during neonatal arch repair | Intra-operative (1 hour) |
| Vocal cord EMG - Burst duration (ms) | Feasibility of performing vocal cord EMG during neonatal arch repair | Intra-operative (1 hour) |
| Vocal cord EMG - Burst frequency (Hz) | Feasibility of performing vocal cord EMG during neonatal arch repair | Intra-operative (1 hour) |
| Vocal cord EMG - Interburst interval (ms) | Feasibility of performing vocal cord EMG during neonatal arch repair | Intra-operative (1 hour) |
| Vocal cord EMG - Signal to noise ratio (mV) | Feasibility of performing vocal cord EMG during neonatal arch repair | Intra-operative (1 hour) |
| Correlation of Vocal cord EMG with post-operative palsy | Vocal cord ultrasound | Post extubation / 1 week post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Neuromuscular blockade | Influence of timing of neuromuscular blockade on EMG signal | Intra-operative (1 hour) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phil Botha, PhD | Contact | +44 121 333 9999 | 9435 | p.botha@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Phil Botha, PhD | Birmingham Women's and Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Children's Hospital | Recruiting | Birmingham | West Midlands | B4 6NH | United Kingdom |
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| ID | Term |
|---|---|
| D061226 | Recurrent Laryngeal Nerve Injuries |
| ID | Term |
|---|---|
| D061224 | Laryngeal Nerve Injuries |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D004576 | Electromyography |
| ID | Term |
|---|---|
| D004568 | Electrodiagnosis |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009213 | Myography |
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| D061223 | Vagus Nerve Injuries |
| D020209 | Cranial Nerve Injuries |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |