Recurrent Nerve Monitoring During Aortic Arch Repair

NCT04994964 | Unknown

• 1 other identifier: 20/BC/CARDIO/NO/444
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (1)

• Neuromuscular blockade

  Intra-operative (1 hour)

Interventions

Electromyography DIAGNOSTIC_TEST

Needle vocal cord electromyography using Medtronic NIM monitor

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Birmingham Women's and Children's NHS Foundation Trust: lead

Study Sites (1)

Birmingham Children's Hospital

Birmingham, West Midlands, B4 6NH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Recurrent Laryngeal Nerve Injuries

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Laryngeal Nerve Injuries; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Injuries; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Officials

• Phil Botha, PhD

  Birmingham Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phil Botha, PhD

CONTACT

+44 121 333 9999; p.botha@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: August 6, 2021
• Study Start: March 23, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: August 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)