Clinical trial NCT04866472: Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Predicted Difficult Airway
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2021-04-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to Control: Video-Laryngoscope and GlideRite Rigid Stylet vs Intervention: Video-Laryngoscope with TCI Articulating Device
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: 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
timeFrame: 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 outcomes:
measure: Ease of intubation using TCI Articulating Device as compaired to GlideRite Rigid Stylet as rated by provider
timeFrame: completed immediately after subject intubation
measure: Need to use a maneuver called "corkscrew" ETT to pass glottis
timeFrame: Period in seconds with an estimated time of 30 to 120 seconds between start of intubation procedure to ETT placement or failure to place
measure: Blood in airway
timeFrame: 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
measure: Time to intubate using either control or intervention
timeFrame: 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
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville School of Medicine
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
References:
citation: Mort TC. The incidence and risk factors for cardiac arrest during emergency tracheal intubation: a justification for incorporating the ASA Guidelines in the remote location. J Clin Anesth. 2004 Nov;16(7):508-16. doi: 10.1016/j.jclinane.2004.01.007.
citation: Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.
citation: Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. doi: 10.1097/00000542-199005000-00010.
citation: Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220.