Clinical validation of NerveTrend versus conventional i-IONM mode of NIM Vital in prevention of recurrent laryngeal nerve events during bilateral thyroid surgery: A randomized controlled trial.

Abstract

The aim of this study was to test the hypothesis that use of NerveTrend™ mode of intermittent neuromonitoring (i-IONM) during thyroidectomy may identify and prevent impending recurrent laryngeal nerve (RLN) injury. A randomized clinical trial. The primary outcome was prevalence of RLN injury on postoperative day 1. In NerveTrend™ group the i-IONM stimulator was used for trending of amplitude and latency changes from initial vagal electromyographic baseline to tailor surgical strategy. Some 264 patients were randomized into the intervention versus the control group, 132 patients each. RLN injury was found on postoperative day 1 in 5/264 (1.89%) nerves at risk (NAR) versus 12/258 (4.65%) NAR whereas staged thyroidectomy was used in 0/132 (0.00%) versus 6/132 (4.54%) patients (p = 0.067 and p = 0.029, respectively). The use of NerveTrend™ mode resulted in tendency towards reduced RLN injury on postoperative day 1 and significant decrease of need for a staged thyroidectomy.