Nerve Integrity Monitoring System (NIM)-Response 3.0® (Medtronic Xomed®, Jacksonville, Florida, USA; REF 8253002, SN 2NR3-2055) with intermittent and continuous monitoring system was used in all cases. High contrast, digital, colour screen, 1024H × 768W pixels, Touch panel 256H × 256W. Impedance: <5 Ohm. Impedance difference: <1 kOhm. Stimulation level: 0.5 mA–1.5 mA (average 1 mA). Initial post-identification stimulation level: 0.5 mA. Frequency: 30 Hz. Stimulus duration: 100 µs. Minimum event threshold: 100 µV. The skin electrodes were placed in the pre-sternal region. The disposable monopolar (Medtronic Xomed) or polyuse (Neurovision Medical) stimulator probe was placed as a dissection tool.
Nim response 3
Manufactured by Medtronic
Sourced in United States
The NIM-Response 3.0 is a medical device designed for intraoperative nerve monitoring. It provides real-time feedback on the functional status of nerves during surgical procedures. The device can be used to detect, identify, and monitor the functional integrity of motor and sensory nerves.
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13 protocols using nim response 3
1
Nerve Integrity Monitoring for Surgical Procedures
2
Intraoperative Neuromonitoring Technique
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IONM was performed using the “Neuro Monitoring SystemTM” (NIM-Response®3.0, Medtronic, Minneapolis, USA). The same-side vagus nerve and RLN were stimulated to evaluate the corresponding vocal cord movement response. Monitoring system settings: threshold 100μV, stimulation current 3mA, amplitude-frequency 30Hz, 4 stimulations per second, and a stimulation period of 100μs. Before stimulating the RLN, the vagus nerve was stimulated routinely, and IONM evoked potential was measured at 90, 100, 110, and 120 minutes after the first identification of RLN and rocuronium use (definition: V1 signal represents the IONM signal produced by stimulating the vagus nerve before dissection, and R1 signal represents the first identified IONM signal when stimulating RLN (15 (link))). Surgical procedures (16 (link)) and signal loss algorithms followed the guidelines of the International Neuro Monitoring Research Group (17 (link), 18 (link)).
3
Intermittent and Continuous IONM Protocols
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The setting of intermittent and continuous IONM equipment, described in more depth elsewhere [5 (link),6 (link),11 (link),12 (link),13 (link)], can be briefly summarized as follows:
For intermittent IONM, standard handheld monopolar stimulation probes, the Neurosign 100™ system (Inomed GmbH, Emmendingen, Germany), and the NIM-response® 2.0 and NIM-response® 3.0 neuromonitoring systems (Medtronic, Jacksonville, FL, USA) were used (4.0 Hz, 100 µs, 1 mA). Beginning in October 2003, electromyographic (EMG) signals generated by stimulation of the ipsilateral vagal nerve were recorded via tube electrodes for quantitative analysis.
For continuous IONM, the Automatic Periodic Stimulation (APS®) circumferential clip electrode was employed together with a standard handheld monopolar stimulation probe (Medtronic, Jacksonville, FL, USA) (4.0 Hz, 100 µs, 1 mA), the NIM-response® 3.0 with a pulse generator for continuous stimulation (1.0 Hz, 100 µs, 1 mA), and an EMG amplifier.
Stable evoked potentials from the vocal muscles were registered via endotracheal tube surface electrodes (NIM Standard Reinforced EMG Endotracheal Tube and NIM Contact Reinforced EMG Endotracheal Tube, Medtronic, Jacksonville, FL, USA). If necessary, the anesthetist was asked to reposition the tracheal tube to maximize the signal amplitude to at least 500 μV.
For intermittent IONM, standard handheld monopolar stimulation probes, the Neurosign 100™ system (Inomed GmbH, Emmendingen, Germany), and the NIM-response® 2.0 and NIM-response® 3.0 neuromonitoring systems (Medtronic, Jacksonville, FL, USA) were used (4.0 Hz, 100 µs, 1 mA). Beginning in October 2003, electromyographic (EMG) signals generated by stimulation of the ipsilateral vagal nerve were recorded via tube electrodes for quantitative analysis.
For continuous IONM, the Automatic Periodic Stimulation (APS®) circumferential clip electrode was employed together with a standard handheld monopolar stimulation probe (Medtronic, Jacksonville, FL, USA) (4.0 Hz, 100 µs, 1 mA), the NIM-response® 3.0 with a pulse generator for continuous stimulation (1.0 Hz, 100 µs, 1 mA), and an EMG amplifier.
Stable evoked potentials from the vocal muscles were registered via endotracheal tube surface electrodes (NIM Standard Reinforced EMG Endotracheal Tube and NIM Contact Reinforced EMG Endotracheal Tube, Medtronic, Jacksonville, FL, USA). If necessary, the anesthetist was asked to reposition the tracheal tube to maximize the signal amplitude to at least 500 μV.
4
Thyroidectomy with Intraoperative Nerve Monitoring
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The thyroidectomies were performed under general anesthesia with ETT intubation. With the IONM group, a short‐acting muscle relaxant was applied only at the beginning. The IONM procedures utilized the IONM system, NIM‐Response 3.0 (Medtronic Ireland Ltd., Dublin, Ireland), and the NIM Trivantage electromyography (EMG) endotracheal intubation tube (Medtronic Xomed Inc, Jacksonville, Florida). Videolaryngoscopy was used for intubation and confirmation of the ETT electrode position relative to the vocal fold before draping. In all cases, the circuit was confirmed by the production of an appropriate EMG signal.
5
Thyroid Surgery with Intraoperative Neuromonitoring
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In this retrospective study, approved by Ethics Committee of Parma, the patients undergoing thyroid surgery associated to IONM have been enrolled consecutively from 21/08/2014 to 30/08/2018. Patient data was collected in a database.
Patient data is related to :
Data collected also concern the type of device used, i.e. NIM Response 3.0 (Medtronic Xomed, Jacksonville, Florida, USA) with intermittent monitoring system (I-IONM) and stimulation specifications; in particular:
1. Amplitude of the Vagus nerve (VN) and RLN as standardized protocol
2. Signal anomalies.
We collected data from I-IONM and not by Continuos IONM because we have interrupted C-IONM after a case of cardiac arrest (15TH patient) during the APS placement.
The statistical software used for data analysis was SPSS.
The utility of the intraoperative neuro-monitoring system was evaluated with the following statistical methods:
Chi square test to asses the rate of vocal cord palsy in traditional and videoassisted procedure.
We considered the values for p <0.05 statistically positive.
Patient data is related to :
Data collected also concern the type of device used, i.e. NIM Response 3.0 (Medtronic Xomed, Jacksonville, Florida, USA) with intermittent monitoring system (I-IONM) and stimulation specifications; in particular:
1. Amplitude of the Vagus nerve (VN) and RLN as standardized protocol
2. Signal anomalies.
We collected data from I-IONM and not by Continuos IONM because we have interrupted C-IONM after a case of cardiac arrest (15TH patient) during the APS placement.
The statistical software used for data analysis was SPSS.
The utility of the intraoperative neuro-monitoring system was evaluated with the following statistical methods:
Chi square test to asses the rate of vocal cord palsy in traditional and videoassisted procedure.
We considered the values for p <0.05 statistically positive.
6
Surgical Approaches for Hearing Preservation
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All the selected patients were surgically treated with TLAB, or transmeatal, or retrosigmoid approaches. The latter encompassed the retrolabyrinthine meatotomy, a modification of the procedure for hearing preservation purposes 16 (link),17 (link).
Intraoperative continuous facial nerve electromyography (EMG) monitoring was adopted with NIM-Response 3.0, Medtronic Xomed Inc. Intraoperative hearing was monitored with NIM-Eclipse, Axom Medtronic Inc.
Intraoperative continuous facial nerve electromyography (EMG) monitoring was adopted with NIM-Response 3.0, Medtronic Xomed Inc. Intraoperative hearing was monitored with NIM-Eclipse, Axom Medtronic Inc.
7
Surgical Approach for Thyroidectomy
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The operative procedure started with neck exploration through a Kocher transverse collar incision from the medial border of one sternocleidomastoid muscle to the medial border of the other, after stretching the strap muscles or dividing the sternothyroid muscle when necessary. The upper thyroid pedicles were then exposed, ligated, and transected. The recurrent laryngeal nerve (RLN) and parathyroid glands were identified and preserved. A neural integrity monitor (NIM) electromyogram tracheal tube (Medtronic@ NIM response 3.0) was used in all cases. Afterward, upward gland delivery was attempted using the index and middle finger. If this manoeuver failed, we extended the approach by making a midline incision from the sternal notch to the lower border of the cricoid cartilage (Fig. 1 ). If thyroidectomy still could not be accomplished, the thoracic surgeon performed partial or complete sternotomy.
8
Standardized Facial Nerve Monitoring in Surgery
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All surgical procedures were standardized and performed by three different surgeons (B.S.K, H.R.W, and J.W.C). Intraoperative facial nerve monitoring was performed using the NIM-Response 3.0 (Medtronic Xomed Inc., Jacksonville, FL, USA) nerve integrity monitor. After sedation, electrodes were inserted into the orbicularis oculi and the orbicularis oris along with a ground electrode. The threshold of the monitor was set at 100 μV. After the operation, TachoSil® (Takeda Pharma A/S, Roskilde, Denmark), a fixed combination of a collagen patch coated with a dry layer of human thrombin (2.0 IU) and fibrinogen (5.5 mg), was cut to suit the resection site and applied over the site with at least 3 min of gentle manual compression according to the manufacturer’s instructions. One JP drain was placed behind the incision line, and the operation was terminated after layer-by-layer repair (Figure 2 ). The drain was removed when the total amount of drainage per day was less than 10 mL for two consecutive days after surgery. Cefotiam (1 g bid) was prescribed postoperatively for all patients until discharge. After discharge, cefditoren pivoxil (100 mg tid) was prescribed for 1 week.
9
Standardized IONM Protocol for Thyroid Surgery
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Standard protocols for general anesthesia and equipment setup were used for IONM of the RLN.3 The channel leads from the surface electrodes of the EMG tube were connected to the neural monitoring system (NIM‐Response 3.0, Medtronic, Jacksonville, Florida). The NIM‐Response stimulus settings were as follows: time window, 50 ms; amplitude scale, 0.2 mV/division; duration, 100 μs; and frequency, 4 Hz. The threshold for the event capture was 100 μV. A standardized neural monitoring protocol was strictly followed, and the highest EMG signal amplitude was recorded at the initial (V1) and final (V2) vagus nerve stimulation. Preoperative and postoperative video recording of vocal cord mobility was performed by flexible laryngofibrescopy. When vocal cord dysfunction was noted, regular follow‐up was conducted until recovery. Vocal cord palsy was defined as permanent if it persisted for 6 months after thyroid surgery.
10
Facial Nerve Monitoring in Parotid Surgery
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All surgical procedures were performed using surgical loupes (2.5x magnification). Medtronic NIM-Response 3.0 (4-channel device; Medtronic Xomed Inc.) was used for intraoperative facial nerve monitoring. Stimuli of 100 microseconds and 0.8 mA were used. The signaling threshold was at least 100 μV.
Patients were not selected based on the tumor location in the parotid gland as it could result in the exclusion of more difficult cases, adversely affecting the study objectivity. This enabled the use of monitoring in patients with tumors in the deep lobe to be assessed. In such cases, we performed a partial parotidectomy, which included both the superficial lobe and the portion of the deep lobe of the parotid gland. The surgeon decided the extent of surgery. The primary goal was facial nerve preservation while sufficiently performing radical surgery.
Patients were not selected based on the tumor location in the parotid gland as it could result in the exclusion of more difficult cases, adversely affecting the study objectivity. This enabled the use of monitoring in patients with tumors in the deep lobe to be assessed. In such cases, we performed a partial parotidectomy, which included both the superficial lobe and the portion of the deep lobe of the parotid gland. The surgeon decided the extent of surgery. The primary goal was facial nerve preservation while sufficiently performing radical surgery.
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