Intubation Devices for Difficult Airway

(DA-TCI Trial)

Recruiting at 1 trial location

Overseen By Emily Drennan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Under 18, Full stomach, Hiatal hernia, GERD, Tracheal narrowing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Single session

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the new TCI Articulating Introducer performs as well as the standard GlideRite Rigid Stylet in assisting with difficult airway intubations. Intubation involves placing a tube in the throat to aid breathing, which can be challenging for patients with specific medical histories or physical traits. The trial seeks participants who require oral intubation and have a history of difficult intubation or conditions such as neck radiation or surgeries. Individuals with a short neck, severe overbite, or sleep apnea may be suitable for this study. As an unphased trial, this study offers the chance to contribute to important research that could enhance intubation techniques for patients with challenging airways.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the TCI Articulating Device is safe for difficult airway intubation?

Research shows that both the GlideRite Rigid Stylet and the TCI Articulating Introducer Device assist with difficult intubations, which occur when inserting a tube into the airway is challenging.

For the GlideRite Rigid Stylet, studies have shown it can increase the success rate of first-attempt intubations. In one study, no failed intubations were reported when it was used, suggesting it is safe and effective.

The TCI Articulating Introducer Device is also promising. Its flexible tip adjusts to the shape of a person's airway. Research suggests it performs well in challenging cases, making intubation easier and safer. It has been shown to be faster and easier to use during difficult intubations compared to some other tools.

Both devices have been tested in medical settings with positive results. No major safety issues have been reported, making them well-tolerated options for patients needing difficult airway intubation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these new intubation devices because they offer innovative solutions for managing difficult airways. The GlideRite Rigid Stylet is designed to provide better maneuverability and control when guiding the tube into the trachea, which can be crucial in challenging situations. The TCI Articulating Introducer Device offers an articulating tip that allows for more precise navigation through tricky airway passages, potentially improving the success rate of intubations. Unlike traditional intubation methods that rely on static guides, these devices are engineered to enhance flexibility and precision, making them promising options for improving patient outcomes during airway management.

What evidence suggests that these intubation devices are effective for difficult airway management?

This trial will compare the effectiveness of two intubation devices for difficult airway management. Research has shown that the GlideRite Rigid Stylet, used by participants in one arm of this trial, aids in breathing tube placement when paired with a video laryngoscope. Studies found it successful in 224 out of 244 attempts. Another study showed that all breathing tubes were placed successfully within three attempts using this tool.

In another arm of this trial, participants will use the TCI Articulating Introducer Device, which is emerging as a promising option for difficult airway situations. It has been found to be faster, easier, and safer than fiber optic bronchoscopy (FOB). In emergency situations where other methods failed, the TCI proved very effective. Both devices have strong evidence supporting their effectiveness in managing challenging airways. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Exclusion Criteria

I am under 18 years old.

I have a known narrowing of my windpipe.

I have a hiatal hernia that has not been treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endotracheal intubation using either the GlideRite Rigid Stylet or the TCI Articulating Introducer with a video laryngoscope

Single session

1 visit (in-person)

Follow-up

Participants are monitored for immediate outcomes such as successful intubation, ease of intubation, and any complications like blood in the airway

Immediate post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• GlideRite Rigid Stylet
• TCI Articulating Introducer Device

Trial Overview 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.

How Is the Trial Designed?

Group I: Video Laryngoscope and TCI Articulating Introducer Experimental Treatment 1 Intervention

Group II: Video Laryngoscope and GlideRite Ridgid Stylet Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

In a study involving 36 participants, both the GlideRite stylet and the conventional malleable stylet (CMS) allowed successful endotracheal intubation on the first attempt in both normal and simulated difficult airway models.

While there was no significant difference in intubation time between the two stylets in a normal airway, the GlideRite demonstrated superior ease of handling and maintained performance in a difficult airway scenario, suggesting it may be a better option for challenging intubations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the GlideRite to the conventional malleable stylet for endotracheal intubation by the Macintosh laryngoscope: a simulation study using manikins. Kong, YT., Lee, HJ., Na, JU., et al.[2020]

In a study of 78 patients, premedication with glycopyrrolate significantly improved visualization of the airway during tracheal intubation using a rigid video-stylet, resulting in better laryngeal view grades compared to the control group.

Glycopyrrolate also reduced the time required for intubation, with an average of 18.5 seconds in the glycopyrrolate group versus 22.0 seconds in the control group, while maintaining stable hemodynamic variables.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does glycopyrrolate premedication facilitate tracheal intubation with a rigid video-stylet?: A randomized controlled trial. Cho, EA., Hwang, SH., Lee, SH., et al.[2021]

The Total Control Introducer (TCI) was successfully used for the first time in combination with a hyperangulated video laryngoscope to perform an awake intubation in a patient with a history of difficult intubation, demonstrating its potential for improving intubation success rates.

The procedure was completed without complications on the first attempt, highlighting the efficacy and safety of using the TCI for navigating the airway during intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awake endotracheal intubation using a hyperangulated video laryngoscope with a Total Control Introducer in a patient with a history of difficult intubation. Campbell, BA., Dziuba, A., Perala, H., et al.[2023]

The S-Guide significantly reduced the total intubation time compared to the Gliderite stylet, with an average time of 58.1 seconds versus 65.3 seconds, indicating it may be more efficient for tracheal intubation in difficult airway scenarios.

Using the S-Guide resulted in fewer instances of arytenoid contact during intubation, suggesting it may be safer and less traumatic for patients, while not increasing postoperative airway discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing S-Guide® and Gliderite® Times to Assist Video laryngoscopic Intubation in Patients with Simulated Difficult Airways: A Single-Blinded Randomized Prospective Study. Nkoulou, C., Maibach, T., Bathory, I., et al.[2022]

The articulating Total Control Introducer (TCI) combined with a video laryngoscope (VL) successfully guided intubation in an 84-year-old woman with a known difficult airway, demonstrating its efficacy in challenging cases.

The use of the TCI allowed for dynamic navigation through the upper airway, enabling successful intubation on the first attempt without complications, highlighting its potential as a safe tool for difficult intubations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Case Report of Intubation With a Total Control Introducer and a Hyperangulated Video Laryngoscope. Pollard, J., Runnels, S., Warrick, C.[2021]

In a study involving 60 patients, novice operators using the GlideScope videolaryngoscope showed no significant difference in intubation time or ease of use between the GlideRite Rigid Stylet (GRS) and the standard malleable stylet (SMS), with both achieving similar performance.

Both the GRS and SMS had a median intubation time of around 60 seconds and similar ease of intubation scores, indicating that the GRS does not provide a performance advantage over the SMS for novice users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized comparison of the GlideRite(®) Rigid Stylet to a malleable stylet for orotracheal intubation by novices using the GlideScope(®). Jones, PM., Loh, FL., Youssef, HN., et al.[2011]

The Parker Flex-It stylet is as effective as the GlideRite Rigid stylet for tracheal intubation using the Glidescope, with no significant difference in total intubation time or first-attempt success rates among 60 patients.

Intubation was significantly easier with the Parker Flex-It stylet, and it resulted in fewer complications such as sore throat and trauma compared to the GlideRite Rigid stylet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parker Flex-It stylet is as effective as GlideRite Rigid stylet for orotracheal intubation by Glidescope. Sheta, SA., Abdelhalim, AA., ElZoughari, IA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5100824/

The Effect of Stylet Choice on the Success Rate of ... Both first-attempt and ultimate success rates were higher with GlideScope intubations in the ED when the rigid stylet was used as compared to the malleable ...

2. jem-journal.com jem-journal.com/article/S0736-4679(11)00747-5/fulltext

The Effect of Stylet Choice on the Success Rate of ... Over the 3-year study period, the GlideScope was used for 368 intubations. When the GlideRite® rigid stylet was used, the operator was successful in 224 of 244 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8841254/

Comparison between GlideRite® rigid stylet and Parker ... All tracheal intubations were successfully performed within three attempts and there were no cases of failed intubation. The Cormack-Lehane ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02177240

Study Details | NCT02177240 | A Comparison of the Flex-it ... The purpose of this study is to determine if the Flex-it® Articulating Stylet or the GlideRite® Rigid Stylet is more effective and less ...

5. link.springer.com link.springer.com/article/10.1007/s12630-010-9440-z

A randomized comparison of the GlideRite® Rigid Stylet to ... The GRS and the SMS have similar performance characteristics when used by novice operators for GlideScope-assisted orotracheal intubation.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01308918

The New GlideRite DLT Stylet®: An Observational Study | ... Correlation Between the Difficult Intubation Score and a Successful Intubation, 1 hour (Post intubation) ; Number of Complications Associated to the GlideRite ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0736467923000045

Comparison of Rigid and Articulating Video Stylets During ... This study compares ease of intubation between the traditional rigid and articulating video stylets during simulated endotracheal intubation.