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

B

Bezmialem Vakif University

Status

Completed

Conditions

Anesthesia Intubation Complication
Pain, Postoperative
Airway Complication of Anesthesia
Intubation; Difficult or Failed

Treatments

Device: Macintosh Laryngoscope
Device: Video Laryngoscope

Study type

Interventional

Funder types

Other

Identifiers

NCT05366582
Ismail02

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Group Macintosh Laryngoscope (ML)
Active Comparator group
Description:
Macintosh laryngoscope is used for intubation after anesthesia induction
Treatment:
Device: Macintosh Laryngoscope
Group Video Laryngoscope (VL)
Active Comparator group
Description:
Video laryngoscope is used for intubation after anesthesia induction
Treatment:
Device: Video Laryngoscope

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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