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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment GlideRite Rigid Stylet, TCI Articulating Introducer Device for difficult airway intubation?

Research shows that the Total Control Introducer (TCI) and video laryngoscope (VL) have been successfully used to intubate patients with difficult airways on the first attempt without complications. Additionally, the GlideRite Rigid Stylet has been found to be as effective as other similar devices for aiding tracheal intubation. ^{1 2 3 4 5}

Is the GlideRite Rigid Stylet safe for use in humans?

The GlideRite Rigid Stylet has been used in studies for tracheal intubation, and while it can assist in the process, there is a risk of injury. However, in one case report using a similar device, intubation was performed without complications. ^{1 4 5 6 7}

How does the TCI Articulating Introducer Device differ from other intubation treatments?

The TCI Articulating Introducer Device is unique because it allows for dynamic navigation through the airway with its flexible tip, making it easier to intubate patients with difficult airways. This device, used with a video laryngoscope, provides better visualization and control during the procedure, increasing the chances of successful intubation on the first attempt without complications. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

First Case Report of Intubation With a Total Control Introducer and a Hyperangulated Video Laryngoscope. [2021]

2. England 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. [2023]

3. Korea (South) 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Does glycopyrrolate premedication facilitate tracheal intubation with a rigid video-stylet?: A randomized controlled trial. [2021]

5. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Parker Flex-It stylet is as effective as GlideRite Rigid stylet for orotracheal intubation by Glidescope. [2022]

6. Turkey 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. [2022]

7. United States 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(®). [2011]