Utilization of Airway Stabilizing Rod to Assist With Laryngeal Mask Airway Guided Fiberoptic Intubation in Adults With Obesity (FASTER)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity, Morbid; Adult
• Intervention / Treatment: Device: Fiberoptic Assisted Endotracheal Rod Intubation

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Morbid Obesity; Elective surgery requiring intubation, Age > 18, BMI > 35 kg/m2	Device: Fiberoptic Assisted Endotracheal Rod Intubation; Fiberoptic-Assisted Endotracheal Rod for Endotracheal Intubation Through a Supraglottic Airway; Other Names: FASTER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Intubation	Time of disconnecting the circuit from supraglottic airway (SGA) to the presence of end tidal carbon dioxide (ETCO2) for intubation.	3 minutes
Number of Intubation Attempts	Defined as failure to capture end tidal carbon dioxide after completion of intubation.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	These complications include number of participants with; Hypoxemia (10% decrease from baseline for 45 seconds); Airway trauma (minor); Esophageal intubation; Laryngospasm; Bronchospasm; Oro-pharyngeal bleeding; Arrhythmia; Emesis; Epistaxis; Dental damage; Post-operative sore throat; Post-operative hoarseness; Accidental extubation during removal of the LMA	Up to 1 day

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Fiberoptic Intubation; faster; Laryngeal mask airway guided intubation; Airway Stabilizing Rod
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Morbid
• Other Study ID Numbers: H-55523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No