Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery

NCT07604623 | Not Yet Recruiting FDA Device

• 1 other identifier: Pro00163938
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

unilateral vocal cord paralysis; unilateral vocal fold immobility; laryngeal nerve injury; recurrent laryngeal nerve injury

Outcome Measures

Primary Outcomes (1)

• Vocal fold mobility

  Vocal fold mobility will be assessed by flexible laryngoscopy on patients post operatively to determine if there has been RLN injury resulting in vocal cord immobility.

  Flexibly laryngoscopy will be performed within four weeks of the aerodigestive or cardiac surgery.

Secondary Outcomes (5)

• Impact on voice in UVFI patients

  The questionnaire will be given within four weeks of the UVFI diagnosis.

• Severity of dysphonia in UVFI patients

  Voice assessment will be completed within four weeks of UVFI diagnosis

• Swallowing outcomes in UVFI patients

  Swallowing assessments will be completed within four weeks of UVFI diagnosis and as recommended by SLP/ENT

• Swallowing symptom burden in UVFI patients

  Questionnaires will be given within four weeks of UVFI diagnosis

• Rate of spontaneous resolution of UVFI

  These outcomes will be measured by flexible laryngoscopy at 3 month and 6 month intervals after the time of UVFI diagnosis

Study Arms (2)

Control Arm

NO INTERVENTION

Participants in this arm will receive standard care during surgery, without the use of intra-operative laryngeal nerve monitoring.

Intervention Arm

EXPERIMENTAL

Participants enrolled in this arm will receive intra-operative recurrent laryngeal nerve monitoring during their surgery to determine if this intervention reduces the risk of developing recurrent laryngeal nerve injury.

Other: Intraoperative laryngeal nerve monitor

Interventions

Intraoperative laryngeal nerve monitor OTHER

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.

Intervention Arm

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• under 18 years of age
• treated at the Stollery Children's Hospital
• will undergo specified aerodigestive or cardiac surgeries that put the recurrent laryngeal nerve at risk

You may not qualify if:

• patients treated at another center
• over 18 years of age at the time of surgery
• severe neurological or genetic comorbidities that affect nerve function

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

MeSH Terms

Conditions

Vocal Cord Paralysis; Laryngeal Nerve Injuries; Recurrent Laryngeal Nerve Injuries

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vagus Nerve Injuries; Cranial Nerve Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Andre Isaac

CONTACT

17804071449; aisaac@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatric Otolaryngology-Head & Neck Surgery

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)