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Compares treatment options for Predicted Difficult Airway
Official title Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation
ClinicalTrials.gov ID: NCT04866472
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients requiring oral endotracheal intubation
- Age 18 years or older
- Group A Criteria (need only one of the following criteria)
- History of difficult intubation
- History of head/neck radiation and prior oral cavity, pharyngeal, or laryngeal surgery Group B Criteria (need three or more of the following)
You likely can't join if
- Any patient under the age of 18 Full stomach, Untreated hiatal hernia Uncontrolled gastroesophageal reflux disease Known tracheal narrowing
See the full eligibility criteria
- Patients requiring oral endotracheal intubation
- Age 18 years or older
- Group A Criteria (need only one of the following criteria)
- History of difficult intubation
- History of head/neck radiation and prior oral cavity, pharyngeal, or laryngeal surgery Group B Criteria (need three or more of the following)
- 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)
- 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
- Oropharyngeal view: modified Mallampati scale of 3 or 4
- Mouth opening \< 4 cm
- Protruding upper teeth (severe overbite)
- History of radiation to the neck
- 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)
- Body Mass Index (BMI) \>35 kg/m2
- Neck circumference .\> 40 cm in females and 43 cm in males measured at the thyroid cartilage
- Obstructive sleep apnea diagnoses or a STOP BANG score 6 and above
- Any patient under the age of 18 Full stomach, Untreated hiatal hernia Uncontrolled gastroesophageal reflux disease Known tracheal narrowing
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.