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video-laryngoscope and TCI Articulating Introducer Device for Difficult Airway (DA-TCI Trial)
N/A
Recruiting
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients requiring oral endotracheal intubation
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
DA-TCI Trial Summary
This trial will compare the feasibility of using the TCI Articulating Device to the GlideRite Rigid Stylet for tracheal intubation in difficult airway cases where intubation is predicted to be difficult.
Who is the study for?
This trial is for adults with a difficult airway, indicated by factors like limited mouth opening, high STOP BANG score (risk of sleep apnea), small thyromental distance, large neck circumference, or history of radiation to the neck. It's also for those who've had head/neck surgery or have certain anatomical challenges. People under 18, with tracheal narrowing, untreated hiatal hernia, full stomach or uncontrolled reflux can't join.Check my eligibility
What is being tested?
The study compares two methods of intubation in patients with challenging airways: one uses the TCI Articulating Introducer Device and video-laryngoscope; the other uses a GlideRite Rigid Stylet with video-laryngoscope. The goal is to see if the TCI device works as well as the GlideRite Stylet.See study design
What are the potential side effects?
Potential side effects may include sore throat, difficulty swallowing post-procedure due to mechanical manipulation during intubation. There might be risks associated with using either introducer device that could lead to tissue injury.
DA-TCI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a tube inserted into my windpipe to help me breathe.
Select...
I cannot move my neck more than 90° or have a neck injury.
Select...
I have had radiation treatment to my neck.
Select...
I have had radiation to my head/neck and surgery in my mouth or throat area.
Select...
My neck circumference is over 40 cm if female, or over 43 cm if male.
Select...
I am 18 years old or older.
Select...
I can't open my mouth wider than 4 cm.
Select...
I have been diagnosed with obstructive sleep apnea or have a high risk for it.
DA-TCI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Blood in airway
Ease of intubation using TCI Articulating Device as compaired to GlideRite Rigid Stylet as rated by provider
Need to use a maneuver called "corkscrew" ETT to pass glottis
+1 moreDA-TCI Trial Design
2Treatment groups
Experimental Treatment
Group I: Video Laryngoscope and TCI Articulating IntroducerExperimental Treatment1 Intervention
Group II: Video Laryngoscope and GlideRite Ridgid StyletExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,820 Total Patients Enrolled
University of UtahOTHER
1,099 Previous Clinical Trials
1,778,529 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is higher than 35, which means you are severely overweight.I need a tube inserted into my windpipe to help me breathe.I cannot move my neck more than 90° or have a neck injury.You have a short distance between the bottom of your chin and the top of your neck when your head is tilted back and your mouth is closed.I have had radiation treatment to my neck.I am under 18 years old.You have experienced difficulty with a previous procedure where a tube was placed into your airway.Your front teeth stick out too much (severe overbite).The distance between the upper part of your breastbone and the bony point of your chin is less than 12 cm when your head is fully extended and your mouth is closed.I have had radiation to my head/neck and surgery in my mouth or throat area.My neck circumference is over 40 cm if female, or over 43 cm if male.I have a known narrowing of my windpipe.I have a hiatal hernia that has not been treated.I am 18 years old or older.I can't open my mouth wider than 4 cm.I have been diagnosed with obstructive sleep apnea or have a high risk for it.You have recently eaten a meal and your stomach is still full.I have severe acid reflux that isn't managed by my current treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Video Laryngoscope and GlideRite Ridgid Stylet
- Group 2: Video Laryngoscope and TCI Articulating Introducer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor currently have any openings for participants?
"Data present on clinicaltrials.gov indicates that this trial is currently in search of participants, with the first post dating back to April 26th 2022 and the last update being June 17th 2022."
Answered by AI
What is the total participant count for this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical study is currently searching for participants; it was first introduced on April 26th 2022 and the most recent modification occurred June 17th 2022. In total, 160 individuals must be recruited from two different sites."
Answered by AI
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