RecruitingNot ApplicableNCT04866472

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

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


Sponsor

University of Louisville

Enrollment

160 participants

Start Date

Apr 26, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two techniques to help with difficult intubation — the placement of a breathing tube in patients predicted to be hard to intubate during anesthesia. Difficult intubation can be a dangerous situation, so having the best tools and techniques is critical. The study compares using a video laryngoscope (camera-guided scope) with either a standard rigid stylet (wire guide) or a specially designed articulating introducer (a flexible guide that can bend to navigate tricky airway anatomy). Researchers want to determine which method is faster, safer, and more successful. Adult patients undergoing planned oral intubation who have features suggesting a potentially difficult airway will be enrolled and randomly assigned to one of the two techniques. You may be eligible if: - You are 18 years or older - You need oral endotracheal intubation for a procedure - You have a history of difficult intubation or prior head/neck surgery/radiation (Group A), OR you meet 3+ criteria for a predicted difficult airway (Group B), such as limited mouth opening, high Mallampati score, obesity, or obstructive sleep apnea You may NOT be eligible if: - You are under 18 - You are considered a full stomach/aspiration risk (untreated hiatal hernia, uncontrolled reflux) - You have known tracheal narrowing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEvideo-laryngoscope and GlideRite Rigid Stylet

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.

DEVICEvideo-laryngoscope and TCI Articulating Introducer Device

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.


Locations(2)

University of Louisville School of Medicine

Louisville, Kentucky, United States

University of Louisville

Louisville, Kentucky, United States

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NCT04866472


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