Neural Integrity Monitor Electromyogram (NIM-EMG) Endotracheal Tube Intubation With Video Laryngoscope

A Comparison of the Videolaryngoscope and Macintosh Laryngoscope for NIM-EMG Endotracheal Tube Placement: Prospective, Double Blind, Randomized Study

Laryngeal nerve monitoring is performed to prevent intraoperative nerve damage in thyroidectomy operations. NIM-EMG intubation tube is used while monitoring the recurrent laryngeal nerve. Care should be taken when placing this tube. Ensure that the electrodes on the tube are in contact with the vocal cords. Both the macintosh laryngoscope and the videolaryngoscope can be used when inserting the NIM-EMG tube. The aim of our study is to compare these two intubation methods.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Airway Complication of Anesthesia; Intubation; Difficult or Failed; Anesthesia Intubation Complication
• Intervention / Treatment: Device: Macintosh Laryngoscope; Device: Video Laryngoscope

Detailed Description

Anesthesiologists play a key role for the medications used for anesthesia and placement of the endotracheal tube in operations with intraoperative monitoring. While placing the NIM-EMG tube, the size of the endotracheal tube is very important so that the tube can contact the vocal cords.

The placement of the tube may change due to reasons such as movement of the neck during the operation. In addition, endotracheal tube placement may be problematic due to poor vision during direct laryngoscopy. Incorrect placement of the tube may result in equipment inoperability and increase the likelihood of injury to the recurrent laryngeal nerve.

Laryngoscopy is a term for tracheal intubation that provides visualization and evaluation of the larynx with its upper airway structures.

Until recently, direct laryngoscopy was considered the standard technique for endotracheal intubation. Recently, a wide variety of methods have been developed for endotracheal intubation. Video laryngoscopes are similar to direct laryngoscopes but provide laryngeal imaging with a small video chip on their blade. This imaging is superior compared to direct laryngoscopy. The aim of the study was to compare the use of direct laryngoscopy and video laryngoscopy in intubation with the NIM-EMG tube, which is routinely used in operations where the recurrent laryngeal nerve (RLN) may be damaged, in terms of intubation success, intubation time, tracheal intubation comfort, hemodynamic responses, surgical satisfaction, and complications that may develop after anesthesia or surgery.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ismail Sumer, MD; Phone Number: 00905332201576; Email: isumer@bezmialem.edu.tr

Study Locations

• Turkey
  • İstanbul, Turkey, 34093
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The American Society of Anesthesiologists (ASA) physical status classification system 1-2
• Age 18-65
• Undergoing Elective Thyroid and Parathyroidectomy surgery
• undergoing Intraoperative Recurrent Laryngeal Nerve Monitoring

Exclusion Criteria:

• History of head and neck surgery
• Body mass index less than 19 or greater than 30
• Muscle relaxant allergy
• Lidocaine allergy
• IDS score >5
• Uncontrolled hypertension, bronchial asthma, tracheal pathology
• undergoing emergency surgery
• Cases that cannot give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Macintosh Laryngoscope (ML); Macintosh laryngoscope is used for intubation after anesthesia induction	Device: Macintosh Laryngoscope; After the induction, laryngoscopy will be performed with a Macintosh laryngoscope after 2 minutes of manual ventilation after muscle relaxant by an anesthesiologist with at least 4 years of experience. Patients will be intubated with the "Medtronic Xomed Nerve Integrity Monitor Standard Reinforced ElectromyographyEndotracheal Tube" (size 6.0, 7.0 or 8.0). The cuff of the intubation tube will be connected to a manometer and inflated at a pressure of 20-30 mmHg until there is no air leak. Intubation will be confirmed by the appearance of end-tidal carbon dioxide (CO2). Failed intubation will be considered if not achieved within 2 minutes
Active Comparator: Group Video Laryngoscope (VL); Video laryngoscope is used for intubation after anesthesia induction	Device: Video Laryngoscope; After the induction, laryngoscopy will be performed with a Video laryngoscope after 2 minutes of manual ventilation after muscle relaxant by an anesthesiologist with at least 4 years of experience. Patients will be intubated with the "Medtronic Xomed Nerve Integrity Monitor Standard Reinforced ElectromyographyEndotracheal Tube" (size 6.0, 7.0 or 8.0). The cuff of the intubation tube will be connected to a manometer and inflated at a pressure of 20-30 mmHg until there is no air leak. Intubation will be confirmed by the appearance of end-tidal CO2. Failed intubation will be considered if not achieved within 2 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intubation attempts	The number of intubation attempts between both groups will be recorded. that patients are intubated will be confirmed by the presence of end tidal carbon dioxide.	during intubation after induction of anesthesia
Difficulty of Laryngoscopy	The Helbo-Hansen scoring system-Steyn Modification will be used to determine the quality of laryngoscopy. Helbo-Hensen et al. with Steyn modification includes five criteria; ease of laryngoscopy, degree of coughing, position of vocal cords, jaw relaxation, and limb movement and graded on a 4-point scale.Total score of 5 will considere to be excellent, 6-10 good, 11-15 poor, and 16-20 bad. Total scores will divide into clinically acceptable and not acceptable scores (total score ≤ 10 acceptable, >10 unacceptable).	during intubation after induction of anesthesia
Difficulty of Intubation	The intubation difficulty scale (IDS) of patients will be used to determine the difficulty of intubation during laryngoscopy, and the Helbo-Hansen scoring system-Steyn Modification will be used to determine the quality of laryngoscopy. Intubation Difficulty Scale (IDS) score, which is a function of seven parameters, resulting in a progressive, quantitative determination of intubation complexity. intubation difficulty may be defined as a measure of the degree of divergence from a predefined "ideal" intubation, i.e., one performed without effort, on the first attempt, practiced by one operator, using one technique, with full visualization of the laryngeal aperture and vocal cords abducted. Such an intubation is accorded an IDS value of 0. Each variation from this defined "ideal" intubation increases the degree of difficulty, the overall score being the sum of all variations from this definition. Impossible intubation is defined by infinity (IDS =[infinity]).	during intubation after induction of anesthesia
NIM-EMG tube placement success	After placing the special tube and checking its level and contact, the grounding subdermal needle electrodes will be placed on the shoulder and all of the electrodes will be connected to the main unit. The impedance of the electrodes will be measured and the tube will be fixed after the device confirms that the impedance values are below 4 kiloohm (kΩ).	during intubation after induction of anesthesia
Intubation time	After anesthesia induction and muscle relaxant, the time will be started when patients who are manually ventilated for 2 minutes are ready for intubation. When successful intubation is proven, the time will be stopped and the duration recorded.	during intubation after induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sore throat	Sore throat of the patients was evaluated as present or absent at the postoperative 30th minute, 2,6 and 24 hours by the patient.	up to 24 hours postoperative period
dysphagia	dysphagia of the patients was evaluated as present or absent at the postoperative 30th minute, 2,6 and 24 hours by the patient.	up to 24 hours postoperative period
patient satisfaction	It will be evaluated by the patient between zero and ten points according to the patient satisfaction scale and the severity of sore throat and hoarseness. The patient satisfaction score is scored over a minimum of 0 points and a maximum of 10 points. A score of 0 means I am not satisfied at all, a score of 10 means very satisfied. A higher score indicates higher satisfaction.	up to 24 hours postoperative period

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: ISMAIL SUMER, MD, Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Videolaryngoscopy; thyroidectomy; airway management; NIM-EMG intubation tube
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Ismail02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No