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

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06916364
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Fiberoptic Assisted Endotracheal Rod Intubation — DEVICE
    Fiberoptic-Assisted Endotracheal Rod for Endotracheal Intubation Through a Supraglottic Airway

Study Details

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.

Key Dates

Start date
Apr 21, 2025
Status verified
May 2025
Primary completion
Jul 31, 2025
Completion
Sep 1, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Morbid Obesity
    Elective surgery requiring intubation, Age \> 18, BMI \> 35 kg/m2

Primary Outcome Measure

Time to Intubation [ Time Frame: 3 minutes ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ben Taub General HospitalHoustonTexas77030-

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