NCT03748342

Second Generation LMA Versus Endotracheal Tube in Obese Patients

The Use of a Second-Generation Laryngeal Mask Airway Versus Endotracheal Tube in Obese Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, comparative study is intended to enroll a total of 148 patients with a BMI 30-49.9 kg/m2 undergoing surgery at Parkland Hospital. The efficacy and performance of a second-generation LMA will be compared to endotracheal intubation. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care.

Conditions

• Obese
• Endotracheal Tube
• Laryngeal Mask Airway

Interventions

Type	Name	Description
DEVICE	Second-Generation Laryngeal Mask Airway	A second-generation LMA will be used for airway management (instead of ETT).

Timeline

• Start date: 2019-06-27
• Primary completion: 2024-02-02
• Completion: 2025-02-03
• First posted: 2018-11-20
• Last updated: 2025-04-17
• Results posted: 2025-04-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study