Clinical trial NCT06916364: Utilization of Airway Stabilizing Rod to Assist With Laryngeal Mask Airway Guided Fiberoptic Intubation in Adults With Obesity
Official title: Utilization of Airway Stabilizing Rod to Assist With Laryngeal Mask Airway Guided Fiberoptic Intubation in Adults With Obesity
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Adult
Obesity, Morbid
Keywords: faster
Laryngeal mask airway guided intubation
Fiberoptic Intubation
Airway Stabilizing Rod
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The FASTER stabilizing rod offers the distinct advantage of intubating through the laryngeal mask airway with a fiberoptic scope via the FASTER stabilizing rod. The device allows for the provider to insert the endotracheal tube (ETT) with visual confirmation using the fiberoptic scope into the trachea. The device then allows for the laryngeal mask airway to be removed while stabilizing the ETT to ensure the ETT does not get dislodged.

The purpose of this protocol is to clinically test the validated prototype that the investigators have built and previously tested in adults with obesity.

The primary aims are to evaluate 1) the time to intubation and 2) the number of intubation attempts. The secondary aim is to note any complications from time to intubation to PACU discharge.

These complications include: Hypoxemia (10% decrease from baseline for 45 seconds)1 Airway trauma (minor) Esophageal intubation Laryngospasm Bronchospasm Oro-pharyngeal bleeding Arrythmia Emesis Epistaxis Dental damage Post-operative sore throat Post-operative hoarseness Accidental extubation during removal of the LMA.

Detailed description: When a patient cannot be ventilated and/or intubated, the guidelines for airway management (ASA difficult airway algorithm) dictate that a laryngeal mask airway (LMA) be used as a rescue device to oxygenate and ventilate the patient. However, an LMA is generally temporary and ultimately needs to be replaced by an endotracheal tube (ETT).

At present, providers can use an exchange catheter through the LMA to place the ETT. However, all current techniques to place the ETT through the LMA are done WITHOUT direct visualization or the ability to provide oxygenation or ventilation. This has the possibility of either accidental tracheal extubation or esophageal intubation as well as the possibility of causing trauma to the airway, particularly of concern in a patient with a difficulty airway.

To bridge this gap, the investigators developed an innovative device called the FASTER that would allow for patients (children through adults) to have an ETT placed through the LMA under direct vision and while being able to oxygenate and ventilate, greatly improving safety.

The first step was to create a prototype that was validated in a mannequin (H-47253 ). Following this validation, the investigators created and successfully performed a feasibility study in children without difficult airway at Texas Children's demonstrating success and no adverse events (H-47253) . Following this feasibility study, and despite the FASTER device being completely external to the patient, given that the study was performed in children, the investigators obtained an IDE from the FDA for study in children specifically with difficulty airways. At present, the investigators have successfully completed an initial study in children (n=20) (H-50120) all with difficulty airways without any adverse events. In this study, children that were previously difficult to intubate having an average of three intubating attempts were intubated in a single attempt in an average of just 66 seconds.

The objective for this protocol is to demonstrate feasibility in using this device in adult obese patients. In this study, the investigators will be using this device that is completely external to the patient and only in adults (not including any protected classes of patients).

Moreover, in the completed study of children with actual difficulty airways, the investigators demonstrated tremendous success and patient benefit without any adverse events. In this protocol, the investigators will not enroll any patients with difficult airway nor any patients in protected classes.

Eligibility criteria: Inclusion Criteria:

* Adult (18-64 yrs),
* Geriatric (65+ yrs)
* BMI \> 35 kg/m2
* elective surgery requiring intubation

Exclusion Criteria:

* pregnant woman
* neonates
* children
* incarcerated patient
* patient refusal

Primary outcomes:
measure: Time to Intubation
timeFrame: 3 minutes
measure: Number of Intubation Attempts
timeFrame: 5 minutes
Secondary outcomes:
measure: Complications
timeFrame: Up to 1 day
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
References:
citation: Kovatsis PG. Continuous ventilation during flexible fiberscopic-assisted intubation via supraglottic airways. Paediatr Anaesth. 2016 Apr;26(4):457-8. doi: 10.1111/pan.12863. No abstract available.
citation: van Zundert TC, Wong DT, van Zundert AA. The LMA-Supreme as an intubation conduit in patients with known difficult airways: a prospective evaluation study. Acta Anaesthesiol Scand. 2013 Jan;57(1):77-81. doi: 10.1111/aas.12011. Epub 2012 Nov 21.
citation: Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.
citation: Joffe AM, Aziz MF, Posner KL, Duggan LV, Mincer SL, Domino KB. Management of Difficult Tracheal Intubation: A Closed Claims Analysis. Anesthesiology. 2019 Oct;131(4):818-829. doi: 10.1097/ALN.0000000000002815.