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
- Adult
- Obesity, Morbid
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Fiberoptic Assisted Endotracheal Rod Intubation — DEVICEFiberoptic-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 ObesityElective surgery requiring intubation, Age \> 18, BMI \> 35 kg/m2
Primary Outcome Measure
Time to Intubation [ Time Frame: 3 minutes ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ben Taub General Hospital | Houston | Texas | 77030 | - |
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