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Second Generation LMA Versus Endotracheal Tube in Obese Patients

NCT03748342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-04-17

Study results available
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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

DEVICE

Second-Generation Laryngeal Mask Airway

A second-generation LMA will be used for airway management (instead of ETT).

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Tiffany S Moon, M.D. · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2024-02-02
Completion
2025-02-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03748342 on ClinicalTrials.gov