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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Macintosh Laryngoscope
Video Laryngoscope
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Intubation; Difficult or Failed focused on measuring Videolaryngoscopy, NIM-EMG intubation tube, thyroidectomy, airway management

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group Macintosh Laryngoscope (ML)

Group Video Laryngoscope (VL)

Arm Description

Macintosh laryngoscope is used for intubation after anesthesia induction

Video laryngoscope is used for intubation after anesthesia induction

Outcomes

Primary Outcome Measures

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.
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).
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]).
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).
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.

Secondary Outcome Measures

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.
dysphagia
dysphagia of the patients was evaluated as present or absent at the postoperative 30th minute, 2,6 and 24 hours by the patient.
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.

Full Information

First Posted
April 29, 2022
Last Updated
March 13, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05366582
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation; Difficult or Failed, Airway Complication of Anesthesia, Pain, Postoperative, Anesthesia Intubation Complication
Keywords
Videolaryngoscopy, NIM-EMG intubation tube, thyroidectomy, airway management

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Anesthesia approach appropriate to the group of the randomized patient before the operation will be selected. The chosen intubation method will be performed by the 1st anesthetist. The patient, the surgeon and the second anesthetist who will follow up intraoperatively and postoperatively will not know the chosen method.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Macintosh Laryngoscope (ML)
Arm Type
Active Comparator
Arm Description
Macintosh laryngoscope is used for intubation after anesthesia induction
Arm Title
Group Video Laryngoscope (VL)
Arm Type
Active Comparator
Arm Description
Video laryngoscope is used for intubation after anesthesia induction
Intervention Type
Device
Intervention Name(s)
Macintosh Laryngoscope
Intervention Description
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
Intervention Name(s)
Video Laryngoscope
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of intubation attempts
Description
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.
Time Frame
during intubation after induction of anesthesia
Title
Difficulty of Laryngoscopy
Description
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).
Time Frame
during intubation after induction of anesthesia
Title
Difficulty of Intubation
Description
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]).
Time Frame
during intubation after induction of anesthesia
Title
NIM-EMG tube placement success
Description
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).
Time Frame
during intubation after induction of anesthesia
Title
Intubation time
Description
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.
Time Frame
during intubation after induction of anesthesia
Secondary Outcome Measure Information:
Title
sore throat
Description
Sore throat of the patients was evaluated as present or absent at the postoperative 30th minute, 2,6 and 24 hours by the patient.
Time Frame
up to 24 hours postoperative period
Title
dysphagia
Description
dysphagia of the patients was evaluated as present or absent at the postoperative 30th minute, 2,6 and 24 hours by the patient.
Time Frame
up to 24 hours postoperative period
Title
patient satisfaction
Description
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.
Time Frame
up to 24 hours postoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismail Sumer, MD
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
İstanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

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

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