Clinical trial NCT05366582: Neural Integrity Monitor Electromyogram (NIM-EMG) Endotracheal Tube Intubation With Video Laryngoscope
Official title: A Comparison of the Videolaryngoscope and Macintosh Laryngoscope for NIM-EMG Endotracheal Tube Placement: Prospective, Double Blind, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Airway Complication of Anesthesia
Pain, Postoperative
Anesthesia Intubation Complication
Keywords: Videolaryngoscopy
NIM-EMG intubation tube
thyroidectomy
airway management
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of intubation attempts
timeFrame: during intubation after induction of anesthesia
measure: Difficulty of Laryngoscopy
timeFrame: during intubation after induction of anesthesia
measure: Difficulty of Intubation
timeFrame: during intubation after induction of anesthesia
measure: NIM-EMG tube placement success
timeFrame: during intubation after induction of anesthesia
measure: Intubation time
timeFrame: during intubation after induction of anesthesia
Secondary outcomes:
measure: sore throat
timeFrame: up to 24 hours postoperative period
measure: dysphagia
timeFrame: up to 24 hours postoperative period
measure: patient satisfaction
timeFrame: up to 24 hours postoperative period
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Ismail Sumer, MD
role: PRINCIPAL_INVESTIGATOR
References: