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Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery

NCT07604623 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-22

No results posted yet for this study

Summary

This research studies whether a device used during surgery can help doctors better protect the nerve that moves a child's vocal cords. Damage to this nerve can affect speaking, swallowing, and sometimes breathing. Children having certain throat, chest, or heart surgeries may be asked to take part. During surgery, some children will have standard care and others will have standard care plus the nerve-monitoring device. After surgery, the team will check vocal cord movement and ask about voice and swallowing. The purpose is to see whether the device can lower the chance of nerve injury and improve care for children in the future.

Conditions

  • Unilateral Vocal Cord Paralysis
  • Unilateral Vocal Cord Paresis

Interventions

OTHER

Intraoperative laryngeal nerve monitor

This nerve monitor will notify surgeons if the recurrent laryngeal nerve is at risk for damage during surgery, by signalling if the nerve is being stretched or manipulated throughout the procedure.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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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 NCT07604623 on ClinicalTrials.gov