Nerve Monitoring for Vocal Cord Protection in Surgery

AI
Overseen ByAndre Isaac
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

I am having surgery that may affect my voice or swallowing nerves.
* treated at the Stollery Children's Hospital
I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo aerodigestive or cardiac surgery with or without intraoperative laryngeal nerve monitoring

Single surgery event
1 visit (in-person)

Postoperative Follow-up

Participants are assessed for vocal fold mobility and complete quality of life questionnaires

Within 4 weeks post-surgery
1 visit (in-person)

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

12 months or until recovery
Every 3 months

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

Group I: Intervention ArmExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

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% ( ...

The 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 ...