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

NCT ID: NCT05366582

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2022-11-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Group Macintosh Laryngoscope (ML)

Macintosh laryngoscope is used for intubation after anesthesia induction

Group Type: ACTIVE_COMPARATOR

Macintosh Laryngoscope

Intervention Type: DEVICE

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

Group Video Laryngoscope (VL)

Video laryngoscope is used for intubation after anesthesia induction

Group Type: ACTIVE_COMPARATOR

Video Laryngoscope

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

İsmail SÜMER

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ismail Sumer, MD

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Ismail02

Identifier Type: -

Identifier Source: org_study_id