Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation
NCT ID: NCT04866472
Last Updated: 2025-02-20
Study Results
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Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2022-04-26
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Video Laryngoscope and GlideRite Ridgid Stylet
video-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.
Video Laryngoscope and TCI Articulating Introducer
video-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.
Interventions
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video-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.
video-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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Utah
OTHER
University of Louisville
OTHER
Responsible Party
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Rainer Lenhardt
Professor, University of Louisville, School of Medicine
Locations
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University of Louisville School of Medicine
Louisville, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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IRB20.0744
Identifier Type: -
Identifier Source: org_study_id
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