Recurrent Nerve Monitoring During Aortic Arch Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-23

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease

NCT04810013

Complex Congenital Heart Disease

COMPLETED

Sleep-disordered Breathing in Infants With Myelomeningocele

NCT04251806

Sleep-disordered Breathing Myelomeningocele

ACTIVE_NOT_RECRUITING

Use of AEEG as Predictor of Long-term Motor Outcome in Neonates With Congenital Heart Disease

NCT01291797

Congenital Heart Disease

TERMINATED

Ultrasound to Detect Vocal Fold Movement in Neurological Disease

NCT05493397

Neurological Disorder Ultrasound Vocal Fold Movement

COMPLETED

Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI

NCT06072495

Velopharyngeal Insufficiency Real Time MRI Cleft Palate

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Laryngeal Nerve Injuries Aortic Arch Hypoplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electromyography

Needle vocal cord electromyography using Medtronic NIM monitor

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

0 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No