Recurrent Nerve Monitoring During Aortic Arch Repair

Recurrent Laryngeal Nerve Injuries Clinical Trial

— PREMAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994964
• Other study ID #: 20/BC/CARDIO/NO/444
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: May 2022

Study information

• Verified date: April 2021
• Source: Birmingham Women's and Children's NHS Foundation Trust
• Contact: Phil Botha, PhD
• Phone: +44 121 333 9999
• Email: p.botha[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Recurrent Laryngeal Nerve Injuries

Intervention

Diagnostic Test:
• Electromyography
Needle vocal cord electromyography using Medtronic NIM monitor

Locations

Country	Name	City	State
United Kingdom	Birmingham Children's Hospital	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Birmingham Women's and Children's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vocal cord EMG - Burst amplitude (mV)	Feasibility of performing vocal cord EMG during neonatal arch repair	Intra-operative (1 hour)
Primary	Vocal cord EMG - Burst duration (ms)	Feasibility of performing vocal cord EMG during neonatal arch repair	Intra-operative (1 hour)
Primary	Vocal cord EMG - Burst frequency (Hz)	Feasibility of performing vocal cord EMG during neonatal arch repair	Intra-operative (1 hour)
Primary	Vocal cord EMG - Interburst interval (ms)	Feasibility of performing vocal cord EMG during neonatal arch repair	Intra-operative (1 hour)
Primary	Vocal cord EMG - Signal to noise ratio (mV)	Feasibility of performing vocal cord EMG during neonatal arch repair	Intra-operative (1 hour)
Primary	Correlation of Vocal cord EMG with post-operative palsy	Vocal cord ultrasound	Post extubation / 1 week post-operatively
Secondary	Neuromuscular blockade	Influence of timing of neuromuscular blockade on EMG signal	Intra-operative (1 hour)