Recurrent Nerve Monitoring During Aortic Arch Repair (PREMAR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Laryngeal Nerve Injuries; Aortic Arch Hypoplasia
• Intervention / Treatment: Diagnostic test: Electromyography

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Phil Botha, PhD; Phone Number: 9435 +44 121 333 9999; Email: p.botha@nhs.net

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B4 6NH
      • Recruiting
      • Birmingham Children's Hospital
      • Contact: Phil Botha, PhD; Phone Number: 9435 +44 121 333 9999; Email: p.botha@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuromuscular blockade	Influence of timing of neuromuscular blockade on EMG signal	Intra-operative (1 hour)

Collaborators and Investigators

• Sponsor: Birmingham Women's and Children's NHS Foundation Trust
• Investigators: Principal Investigator: Phil Botha, PhD, Birmingham Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2021
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): May 1, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (ACTUAL): August 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Wounds and Injuries; Disease Attributes; Otorhinolaryngologic Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Laryngeal Diseases; Cranial Nerve Injuries; Vagus Nerve Injuries; Recurrence; Laryngeal Nerve Injuries; Recurrent Laryngeal Nerve Injuries
• Other Study ID Numbers: 20/BC/CARDIO/NO/444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No