The incidence and risk factors for cardiac arrest during emergency tracheal intubation: a justification for incorporating the ASA Guidelines in the remote location.
Thomas C Mort
https://pubmed.ncbi.nlm.nih.gov/15590254Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04866472
Comparison of Video Laryngoscope With GlideRite Rigid Stylet Versus Video Laryngoscope With TCI Articulating Introducer for Endotracheal Intubation in Predicted Difficult Airways
Led by University of Louisville · Updated on 2025-02-20
160
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
Sponsors
U
University of Louisville
Lead Sponsor
U
University of Utah
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the TCI Articulating Device combined with a video-laryngoscope for patients predicted to have difficult airways during endotracheal intubation. This study aims to determine if this device performs equivalently to the GlideRite Rigid Stylet used with a video-laryngoscope. The trial is a multi-centered, prospective, randomized controlled study designed to compare these two devices in this specific patient group. Participants will be divided into two groups: one using a video-laryngoscope with the GlideRite Rigid Stylet and the other using a video-laryngoscope with the TCI Articulating Introducer Device. Standard practices such as muscle relaxation and monitoring will be followed. Intubation will be performed using appropriately sized blades and endotracheal tubes based on gender, with each device used according to its specific method. Both devices are lubricated before use, and correct tube placement is confirmed by capnography and auscultation. During the study, researchers will measure the time taken to successfully intubate, ease of intubation as rated by the provider, use of special maneuvers, and presence of blood in the airway. These measures will be timed from the start of intubation attempts to tube placement or failure. Patients will be monitored carefully throughout the procedure, and the total time for each intubation is expected to be between 30 and 120 seconds. The study will continue until April 2027.
CONDITIONS
Brief Title
Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients requiring oral endotracheal intubation
- Age 18 years or older
- History of difficult intubation or history of head/neck radiation and prior oral cavity, pharyngeal, or laryngeal surgery (need at least one)
- Or at least three of the following: thyromental distance less than 6 cm, sternomental distance less than 12 cm, modified Mallampati score of 3 or 4, mouth opening less than 4 cm, severe overbite, history of neck radiation, limited neck movement greater than 90 degrees, body mass index over 35 kg/m2, neck circumference over 40 cm in females or 43 cm in males, obstructive sleep apnea or STOP BANG score 6 and above
You will not qualify if you...
- Patients under 18 years old
- Full stomach
- Untreated hiatal hernia
- Uncontrolled gastroesophageal reflux disease
- Known tracheal narrowing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single procedure lasting approximately 30 to 120 seconds
Participants undergo endotracheal intubation using either a video-laryngoscope with GlideRite Rigid Stylet or a video-laryngoscope with TCI Articulating Introducer during surgery.
1 procedure visit (in-person, in operating room)
Trial Site Locations
Total: 2 locations
1
University of Louisville School of Medicine
Louisville, Kentucky, United States, 40202
Actively Recruiting
2
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
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Research Team
R
Reiner Lenhardt, MD
E
Emily Drennan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
The importance of first pass success when performing orotracheal intubation in the emergency department.
John C Sakles, Stephen Chiu, Jarrod Mosier...
https://pubmed.ncbi.nlm.nih.gov/23574475Adverse respiratory events in anesthesia: a closed claims analysis.
R A Caplan, K L Posner, R J Ward...
https://pubmed.ncbi.nlm.nih.gov/2339799Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial.
Rainer Lenhardt, Mary Tyler Burkhart, Guy N Brock...
https://pubmed.ncbi.nlm.nih.gov/24842175