Unilateral Vocal Cord ParalysisNCT07604623
Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery
A study testing Intraoperative laryngeal nerve monitor in people with Unilateral Vocal Cord Paralysis and Unilateral Vocal Cord Paresis, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Vocal Cord Paralysis, Unilateral Vocal Cord Paresis
- What is being tested?
- Intraoperative laryngeal nerve monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2027to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- patients treated at another center
- over 18 years of age at the time of surgery
- severe neurological or genetic comorbidities that affect nerve function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Stollery Children's Hospital
Edmonton, Alberta, T6G2B7
Andre Isaac, MD, MSc, FRCSC, 7804071449, aisaac@ualberta.ca
Amy Callaghan, MSc, acallagh@ualberta.ca
About this study
Official title: 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.
Read the 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.
- Being tested
- Intraoperative laryngeal nerve monitor
- Keywords
- unilateral vocal cord paralysis, unilateral vocal fold immobility, laryngeal nerve injury, recurrent laryngeal nerve injury
- Medical subject headings
- Vocal Cord Paralysis, Laryngeal Nerve Injuries, Recurrent Laryngeal Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative laryngeal nerve monitorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intraoperative laryngeal nerve monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Flexibly laryngoscopy will be performed within four weeks of the aerodigestive or cardiac surgery.
Secondary outcomes (5)
Impact on voice in UVFI patients
Voice-related quality of life questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: These outcomes will be measured by flexible laryngoscopy at 3 month and 6 month intervals after the time of UVFI diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Vocal Cord ParalysisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604623
- Sponsor's protocol ID
- Pro00163938
- Status last verified
- Oct 2026
- First submitted
- 12 May 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery: A Randomized Double-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT07604623
- Acronym / sponsor ID
- Pro00163938
- Keywords
- unilateral vocal cord paralysis, unilateral vocal fold immobility, laryngeal nerve injury, recurrent laryngeal nerve injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Intraoperative laryngeal nerve monitorParticipants 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- patients treated at another center
- over 18 years of age at the time of surgery
- severe neurological or genetic comorbidities that affect nerve function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative laryngeal nerve monitorThis 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. | Other | Intervention Arm |
Primary outcome
Vocal fold mobility
Time frame: Flexibly laryngoscopy will be performed within four weeks of the aerodigestive or cardiac surgery.
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.
5 secondary outcomes
Impact on voice in UVFI patients
Time frame: The questionnaire will be given within four weeks of the UVFI diagnosis.
Severity of dysphonia in UVFI patients
Time frame: Voice assessment will be completed within four weeks of UVFI diagnosis
Swallowing outcomes in UVFI patients
Time frame: Swallowing assessments will be completed within four weeks of UVFI diagnosis and as recommended by SLP/ENT
Swallowing symptom burden in UVFI patients
Time frame: Questionnaires will be given within four weeks of UVFI diagnosis
Rate of spontaneous resolution of UVFI
Time frame: These outcomes will be measured by flexible laryngoscopy at 3 month and 6 month intervals after the time of UVFI diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Unilateral Vocal Cord Paralysis
Enrolling by invitationObservational study
Outcomes Tracking in Unilateral Vocal Fold Paralysis (UVFP) and Atrophy After Medialization Laryngeal Surgery
Unilateral Vocal Cord Paralysis, Vocal Cord Atrophy
Active, not recruiting
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement
Bilateral Vocal Cord Paralysis
Recruiting
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
Paralysis, Unilateral, Vocal Cord
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative laryngeal nerve monitor in people with Unilateral Vocal Cord Paralysis and Unilateral Vocal Cord Paresis, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andre Isaac (17804071449, aisaac@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocal fold mobility (time frame: Flexibly laryngoscopy will be performed within four weeks of the aerodigestive or cardiac surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.