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

Not Applicable

Recruiting

• Conditions: Predicted Difficult Airway
• Interventions: Device: video-laryngoscope and TCI Articulating Introducer Device; Device: video-laryngoscope and GlideRite Rigid Stylet

• Registration Number: NCT04866472
• Lead Sponsor: University of Louisville

Brief 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.

Detailed Description

Multi-Centered, Prospective, Randomized, Control Trial

Study Timeline

• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-29
• Study Start: 2022-04-26
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-12
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients requiring oral endotracheal intubation

• Age 18 years or older

• Group A Criteria (need only one of the following criteria)

  1. History of difficult intubation
  2. History of head/neck radiation and prior oral cavity, pharyngeal, or laryngeal surgery

Group B Criteria (need three or more of the following)

1. 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)
2. 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
3. Oropharyngeal view: modified Mallampati scale of 3 or 4
4. Mouth opening < 4 cm
5. Protruding upper teeth (severe overbite)
6. History of radiation to the neck
7. 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)
8. Body Mass Index (BMI) >35 kg/m2
9. Neck circumference .> 40 cm in females and 43 cm in males measured at the thyroid cartilage
10. Obstructive sleep apnea diagnoses or a STOP BANG score 6 and above

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Exclusion Criteria

Any patient under the age of 18 Full stomach, Untreated hiatal hernia Uncontrolled gastroesophageal reflux disease Known tracheal narrowing

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video Laryngoscope and TCI Articulating Introducer	video-laryngoscope and TCI Articulating Introducer Device	-
Video Laryngoscope and GlideRite Ridgid Stylet	video-laryngoscope and GlideRite Rigid Stylet	-

Primary Outcome Measures

Name	Time	Method
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	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	successful intubation

Secondary Outcome Measures

Name	Time	Method
Ease of intubation using TCI Articulating Device as compaired to GlideRite Rigid Stylet as rated by provider	completed immediately after subject intubation	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
Blood in airway	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	Provider reports blood in airway after the end of the intubation
Time to intubate using either control or intervention	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	Time from first view of glottis to ETT placement or failure to place, up to three attempts using each technique
Need to use a maneuver called "corkscrew" ETT to pass glottis	Period in seconds with an estimated time of 30 to 120 seconds between start of intubation procedure to ETT placement or failure to place	provider confirms use of "corkscrew" maneuver during or after intubation, scale as yes or no

Trial Locations

Locations (2)

University of Louisville School of Medicine; 🇺🇸 Louisville, Kentucky, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States