Clinical Validation of NerveTrend vs. NerveAssure Mode of Intraoperative Neuromonitoring in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery: A Randomized Controlled Trial.

Objective: To compare two modes of NIM Vital application in thyroid surgery: NerveTrendTM vs. NerveAssureTM with respect to the prevalence of postoperative recurrent laryngeal nerve (RLN) injury.

Background: The use of NerveTrendTM compared to intermittent neuromonitoring (i-IONM) in thyroid surgery has recently been reported to result in a tendency towards reduced RLN injury on postoperative day 1 (POD1) and a significant decrease in the need for staged thyroidectomy. However, it remains unclear whether this technique is inferior to continuous neuromonitoring (NerveAssureTM).

Methods: prospective, single-center, two-arm randomized clinical trial. The primary outcome was the prevalence of RLN injury on POD1. In the NerveTrendTM group, the surgeon-operated i-IONM stimulation probe was used for trending amplitude and latency changes from the initial vagal electromyographic baseline (at pace based on surgical judgment) to tailor the surgical strategy. In the NerveAssureTM group, it was performed using an Automatic Periodic Stimulation (APS) electrode placed on the vagus nerve.

Results: A total of 264 patients were randomized into the intervention group (NerveTrendTM) and the control group (NerveAssureTM), 132 patients, and 264 nerves at risk (NAR), each. RLN injury was found on POD1 in 3/264 (1.14%) versus 1/264 (0.38%) NAR, whereas staged thyroidectomy was not necessary in any of the patients in the study (P=0.624 and P=1.0, respectively).

Conclusions: NerveTrendTM mode was not inferior to the NerveAssureTM mode in thyroid surgery with respect to the risk of RLN injury, and both modes had the potential to abolish the need for staged thyroidectomy.