Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation

Study Overview
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Brief Summary
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This study will assess the feasibility of using the TCI Articulating Device with video-laryngoscope in predictive, difficult airway, endotracheal intubation cases. It is meant to show the use of this device is equivalent to using the GlideRite Rigid Stylet with video-laryngoscope.

Detailed Description
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Multi-Centered, Prospective, Randomized, Control Trial

Official Title
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Comparison of Video Laryngoscope (VLS) With GlideRite Ridge Stylet vs Video Laryngoscope With the TCI Articulating Indroducer for Endotracheal Intubation in Predicted Difficult Airways. A Prospective Randomized Control Trial

Conditions
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Predicted Difficult Airway

Intervention / Treatment
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* Device: video-laryngoscope and GlideRite Rigid Stylet
* Device: video-laryngoscope and TCI Articulating Introducer Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring oral endotracheal intubation Age 18 years or older Group A Criteria (need only one of the following criteria) History of difficult intubation History of head/neck radiation and prior oral cavity, pharyngeal, or laryngeal surgery Group B Criteria (need three or more of the following) Thyromental distance <6 cm (Defined as distance measured from the thyroid notch to the tip of the jaw with the head extended and the mouth closed) Sternomental distance < 12 cm (Defined as distance measured as the straight line between the upper border of the manubrium sterni and the bony point of the mentum with the head in full extension and the mouth closed Oropharyngeal view: modified Mallampati scale of 3 or 4 Mouth opening < 4 cm Protruding upper teeth (severe overbite) History of radiation to the neck Limited neck movement: inability to extend and flex neck >90° from full extension to full flexion or presence of cervical spine pathologies and fractures (e.g., C-collar in place) Body Mass Index (BMI) >35 kg/m2 Neck circumference .> 40 cm in females and 43 cm in males measured at the thyroid cartilage Obstructive sleep apnea diagnoses or a STOP BANG score 6 and above Exclusion Criteria: Any patient under the age of 18 Full stomach, Untreated hiatal hernia Uncontrolled gastroesophageal reflux disease Known tracheal narrowing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization to Control: Video-Laryngoscope and GlideRite Rigid Stylet vs Intervention: Video-Laryngoscope with TCI Articulating Device
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Video Laryngoscope and GlideRite Ridgid Stylet<br> | Device: video-laryngoscope and GlideRite Rigid Stylet<br>* Once subject is in the operating room, standard monitoring will be instituted including nerve stimulator. Induction will follow standard practice.Once full muscle relaxation is confirmed with a train of four of 0/4 laryngoscopy will be preformed using a video-laryngoscope (VLS) with a #3 blade for women and a #4 blade men. Endotracheal intubation will be performed using a #7 endotracheal tube in women and # 8 in men using the GlideRite Rigid Stylet. The stylet will be shaped to the curvature of the blade of the VLS and lubricated with a water-based lubricant. After successful tracheal intubation the circuit will be connected and ventilation confirmed with capnography and auscultation.<br>|
| Experimental: Video Laryngoscope and TCI Articulating Introducer<br> | Device: video-laryngoscope and TCI Articulating Introducer Device<br>* In the operating room, standard monitoring will be instituted including nerve simulator. Induction will follow standard practice. Once full muscle relaxation is achieved (train of four of 0/4) laryngoscopy will be performed using a video-laryngoscope (VLS) using a #3 blade in women and a #4 blade in men. A #7 endotracheal tube will be used for women and a #8 for men. Endotracheal intubation will be performed by placing the tube on the back of the TCI articulating introducer, after shaft is lubricated with a water based lubricant. The tip of the TCI articulating introducer will be maneuvered into the trachea and advanced until the green zone of the introducer shaft is adjacent to the glottis. The handle of the articulating introducer will then be removed and the ETT will be advanced over the articulating introducer and into the trachea via Seldinger's technique. Once in place the respiratory circuit will be connected and confirmed with capnography and auscultation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to successful intubation using a combination of video-laryngoscope and TCI Articulating Device will be equilivant to intubation success usinging a combination of video-laryngoscope and GlideRite Rigid Stylet | successful intubation | time measured in seconds with an estimated time of 30 to 120 seconds from the start of intubation to endotracheal tube placement verified by CO2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of intubation using TCI Articulating Device as compaired to GlideRite Rigid Stylet as rated by provider | completion by provider of Ease of Intubation visual score scale measured from 0 to 100, with 0 being impossible intubation and 100 perfectly easy intubation | completed immediately after subject intubation | 
| Need to use a maneuver called corkscrew ETT to pass glottis | provider confirms use of corkscrew maneuver during or after intubation, scale as yes or no | Period in seconds with an estimated time of 30 to 120 seconds between start of intubation procedure to ETT placement or failure to place | 
| Blood in airway | Provider reports blood in airway after the end of the intubation | Period in seconds with an estimated time of 30 to 120 seconds between start of use of TCI Articulating Device to placement of ETT tube or failure to place | 
| Time to intubate using either control or intervention | Time from first view of glottis to ETT placement or failure to place, up to three attempts using each technique | Time measured in seconds, with an estimated time of 30 to 120 seconds, from time of first view of glottis to time ETT placement or failure to place |