MedTrace Logo

Recurrent Nerve Monitoring During Aortic Arch Repair

NCT04994964 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-08-06

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Electromyography

Needle vocal cord electromyography using Medtronic NIM monitor

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Phil Botha, PhD · Birmingham Women's and Children's Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04994964 on ClinicalTrials.gov