Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery

Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery: A Randomized Double-blinded Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Unilateral Vocal Cord Paralysis; Unilateral Vocal Cord Paresis
• Intervention / Treatment: Other: Intraoperative laryngeal nerve monitor

Detailed Description

Purpose The purpose of this study is to compare the rate of recurrent laryngeal nerve (RLN) injury in pediatric patients undergoing aerodigestive and cardiac surgeries with intraoperative laryngeal nerve monitoring (IOLNM) versus standard surgery without IOLNM. The study also aims to evaluate whether continuous electromyography monitoring reduces clinically detectable postoperative nerve dysfunction in children undergoing RLN-risk surgery.

Hypothesis The investigators hypothesize that patients who undergo surgery with IOLNM will have a lower rate of RLN injury, less severe nerve injury when injury occurs, and a shorter duration of neuropraxia/vocal cord paresis compared with patients who undergo standard surgery without monitoring.

Justification Vocal cord paralysis is a recognized complication of pediatric thyroid, airway, esophageal, and cardiac surgery because the RLN is vulnerable along its course through the neck and chest. RLN injury can lead to dysphonia, dysphagia, aspiration, and respiratory insufficiency, making prevention clinically important. Existing evidence suggests IOLNM may reduce RLN injury, especially in pediatric surgery where some procedures have reported injury rates as high as 40%; however, the current literature is limited by a lack of prospective randomized studies and lack of direct prospective comparison against standard surgical care. The recent availability of pediatric-compatible monitoring electrodes also makes this question feasible to study in infants and young children.

Research Method/Procedures This is a single-centre, randomized, double-blinded, controlled clinical trial conducted at Stollery Children's Hospital. Eligible participants are patients under 18 years of age undergoing RLN-risk surgery involving the trachea, esophagus, thyroid, mediastinum, ductus arteriosus, or aortic arch, with specified inclusion and exclusion criteria. Participants, study investigators, clinicians performing follow-up flexible laryngoscopy, and video raters are blinded to allocation; surgeons and personnel directly involved in intraoperative care cannot be blinded.

For participants randomized to the intervention arm, IOLNM is used during a single surgery. Surgery otherwise proceeds according to standard of care. Within four weeks of their surgery, participants are seen in follow-up by Dr. Isaac or another pediatric otolaryngologist. At that visit, they complete the PedsQL, PVRQOL, Pediatric VHI, and dysphagia questionnaires, and undergo video-recorded flexible fiberoptic laryngoscopy. The recorded laryngoscopy is anonymized and reviewed by a blinded independent expert. For patients with RLN injury, further clinical follow-up and repeat laryngoscopy every three months for at least one year or until recovery occur as part of standard care.

Safety monitoring is performed during surgery, the postoperative hospital stay, and follow-up visits. Adverse events related to IOLNM include, but are not limited to, laryngeal trauma, airway bleeding, or inflammation, and are reported to the study coordinator, principal investigator, and local HREB in accordance with institutional and Health Canada standards.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andre Isaac; Phone Number: 17804071449; Email: aisaac@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G2B7
      • Stollery Children's Hospital
      • Contact: Andre Isaac, MD, MSc, FRCSC; Phone Number: 7804071449; Email: aisaac@ualberta.ca
      • Contact: Amy Callaghan, MSc; Email: acallagh@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Participants in this arm will receive standard care during surgery, without the use of intra-operative laryngeal nerve monitoring.
Experimental: Intervention Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on voice in UVFI patients	Voice-related quality of life questionnaire	The questionnaire will be given within four weeks of the UVFI diagnosis.
Severity of dysphonia in UVFI patients	Dysphonia measured by acoustic analysis and GRBAS assessment	Voice assessment will be completed within four weeks of UVFI diagnosis
Swallowing outcomes in UVFI patients	Dysphagia will be measured by FEES and/or VFSS assessments	Swallowing assessments will be completed within four weeks of UVFI diagnosis and as recommended by SLP/ENT
Swallowing symptom burden in UVFI patients	Impact on quality of life from dysphagia will be measured using validated questionnaires	Questionnaires will be given within four weeks of UVFI diagnosis
Rate of spontaneous resolution of UVFI	Rate of vocal fold motion recovery, and time to recovery, assessed by flexibly laryngoscopy	These outcomes will be measured by flexible laryngoscopy at 3 month and 6 month intervals after the time of UVFI diagnosis

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: unilateral vocal cord paralysis; unilateral vocal fold immobility; laryngeal nerve injury; recurrent laryngeal nerve injury
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Laryngeal Diseases; Paralysis; Vagus Nerve Diseases; Cranial Nerve Injuries; Vagus Nerve Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vocal Cord Paralysis; Laryngeal Nerve Injuries; Recurrent Laryngeal Nerve Injuries
• Other Study ID Numbers: Pro00163938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes