Nerve Monitoring for Vocal Cord Protection in Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether an intraoperative laryngeal nerve monitor, a special device used during surgery, can protect the nerve controlling a child's vocal cords. Damage to this nerve can impair speaking, swallowing, and breathing. Some children will undergo surgery with this device, while others will have surgery without it. The trial aims to determine if the device reduces the risk of nerve injury. It is suitable for children undergoing certain throat, chest, or heart surgeries at Stollery Children's Hospital. As an unphased trial, it provides a unique opportunity for patients to contribute to innovative research that could enhance surgical outcomes for children.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that this device is safe for use in surgery?
Research has shown that using monitors to check the laryngeal nerve during surgery is generally safe. These monitors help locate and protect the nerve that controls vocal cords, which is crucial during major changes in the throat area.
For example, one study with over 2,500 patients found that this monitor significantly reduced the risk of nerve damage. Another study demonstrated that it greatly lowers the chance of temporary nerve injuries, aiding faster voice recovery after surgery.
Overall, this device is well-tolerated and has a strong track record for improving nerve safety during surgeries.12345Why are researchers excited about this trial?
Unlike the standard surgical care that doesn't use nerve monitoring, the intraoperative laryngeal nerve monitor aims to protect vocal cords during surgery by actively tracking the recurrent laryngeal nerve. Researchers are excited about this technique because it offers real-time feedback during surgery, potentially reducing the risk of nerve injury and preserving vocal function. This approach could lead to safer outcomes for patients undergoing procedures near the vocal cords, offering a significant improvement over traditional methods that do not provide this level of nerve protection.
What evidence suggests that this nerve-monitoring device is effective for protecting vocal cords during surgery?
This trial will compare standard care during surgery with the use of intraoperative nerve monitoring (IONM) to protect the vocal cords. Research has shown that IONM can reduce the risk of vocal cord nerve injury during surgery. One study found that the risk of injury to the recurrent laryngeal nerve dropped from 3.2% to 2.3% with IONM. Another study demonstrated that temporary vocal cord paralysis occurred less often with IONM—2.0% compared to 10.0% without it. In children, IONM effectively prevents nerve injuries that can affect vocal cord movement. Overall, IONM offers better protection for the vocal cords during surgeries.23456
Are You a Good Fit for This Trial?
This trial is for children under 18 who are having certain throat, chest, or heart surgeries at Stollery Children's Hospital that could put the nerve controlling their vocal cords at risk.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo aerodigestive or cardiac surgery with or without intraoperative laryngeal nerve monitoring
Postoperative Follow-up
Participants are assessed for vocal fold mobility and complete quality of life questionnaires
Extended Follow-up
Participants with RLN injury undergo further clinical follow-up and repeat laryngoscopy every three months for at least one year or until recovery
What Are the Treatments Tested in This Trial?
Interventions
- Intraoperative laryngeal nerve monitor
Trial Overview
The study compares standard surgery care to standard care plus a device that monitors the nerve controlling vocal cord movement during surgery. Children are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Participants in this arm will receive standard care during surgery, without the use of intra-operative laryngeal nerve monitoring.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Citations
Effectiveness of the recurrent laryngeal nerve monitoring ...
The results showed that IONM reduced the location time of the RLN and improved the recognition rate of the superior laryngeal nerve. The ...
Intraoperative recurrent laryngeal nerve monitoring versus ...
Overall, 49.8% of RLNs underwent IONM (2480/4978) and 50.2% underwent VA (2497/4978). Overall RLNI rates were higher for VA (VA: 3.2% (80/2497) vs. IONM: 2.3% ( ...
3.
journals.lww.com
journals.lww.com/md-journal/fulltext/2025/09190/the_value_of_intraoperative_neuromonitoring_and.85.aspxThe value of intraoperative neuromonitoring and...
Transient VFP occurred in 1.1% (IONM) versus 1.9% (NSLP; P = .163) and permanent VFP occurred in 0.5% and 0.8% of patients respectively (P = .
Intraoperative neuromonitoring reduces vocal cord injury in ...
The IONM group demonstrated significantly lower rates of temporary vocal cord paralysis (2.0% vs 10.0%, P = 0.038) and higher nerve ...
Intraoperative Nerve Monitoring Parameters and Risk of ...
Conclusions: IONM significantly reduces RLNI risk, particularly for unilateral injuries, with optimal protection achieved through continuous monitoring, low ...
Intraoperative recurrent laryngeal nerve monitoring in ... - PMC
It can represent a safe and reliable indicator for the recurrent laryngeal nerve identification when facing with major anatomical changes hazarding laryngeal ...
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