Intubation; Difficult or FailedNCT05366582
Neural Integrity Monitor Electromyogram (NIM-EMG) Endotracheal Tube Intubation With Video Laryngoscope
A study testing Macintosh Laryngoscope and Video Laryngoscope in people with Intubation; Difficult or Failed and Airway Complication of Anesthesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Airway Complication of Anesthesia, Pain, Postoperative
- What is being tested?
- Macintosh Laryngoscope and Video Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Macintosh Laryngoscope, Video Laryngoscope
- Keywords
- Videolaryngoscopy, NIM-EMG intubation tube, thyroidectomy, airway management
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh LaryngoscopeDevice
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
Video LaryngoscopeDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group Macintosh Laryngoscope (ML) | Active comparator | Macintosh laryngoscope is used for intubation after anesthesia induction Receives: Device: Macintosh Laryngoscope |
| Group Video Laryngoscope (VL) | Active comparator | Video laryngoscope is used for intubation after anesthesia induction Receives: Device: Video Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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]).
Measured: 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).
Measured: 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.
Measured: during intubation after induction of anesthesia
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: up to 24 hours postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start10 May 2022
- Primary completion15 Sep 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail SÜMER, Bezmialem Vakif University
- Investigators
- Ismail Sumer, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366582
- Sponsor's protocol ID
- Ismail02
- Status last verified
- Mar 2023
- First submitted
- 29 Apr 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Videolaryngoscope and Macintosh Laryngoscope for NIM-EMG Endotracheal Tube Placement: Prospective, Double Blind, Randomized Study
- ClinicalTrials.gov ID
- NCT05366582
- Acronym / sponsor ID
- Ismail02
- Conditions
- Intubation; Difficult or Failed, Airway Complication of Anesthesia, Pain, Postoperative, Anesthesia Intubation Complication
- Keywords
- Videolaryngoscopy, NIM-EMG intubation tube, thyroidectomy, airway management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Macintosh Laryngoscope (ML) | Active comparator | Device: Macintosh LaryngoscopeMacintosh laryngoscope is used for intubation after anesthesia induction |
| Group Video Laryngoscope (VL) | Active comparator | Device: Video LaryngoscopeVideo laryngoscope is used for intubation after anesthesia induction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- History of head and neck surgery
- Body mass index less than 19 or greater than 30
- Muscle relaxant allergy
- Lidocaine allergy
- IDS score >5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macintosh LaryngoscopeAfter 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 | Device | Group Macintosh Laryngoscope (ML) |
| Video LaryngoscopeAfter 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 | Device | Group Video Laryngoscope (VL) |
Primary outcome
Number of intubation attempts
Time frame: during intubation after induction of anesthesia
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
Time frame: during intubation after induction of anesthesia
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
Time frame: during intubation after induction of anesthesia
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
Time frame: during intubation after induction of anesthesia
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
Time frame: during intubation after induction of anesthesia
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.
3 secondary outcomes
sore throat
Time frame: up to 24 hours postoperative period
dysphagia
Time frame: up to 24 hours postoperative period
patient satisfaction
Time frame: up to 24 hours postoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Sumer, MD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh Laryngoscope and Video Laryngoscope in people with Intubation; Difficult or Failed and Airway Complication of Anesthesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intubation attempts (time frame: during intubation after induction of anesthesia). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.