Second-Generation LMA for Obesity

Recruiting at 1 trial location

Overseen By Tiffany S Moon, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Advanced pulmonary, cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

97 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Tiffany S Moon, M.D.

Principal Investigator

University of Texas

Eligibility Criteria

This trial is for adults aged 18-80 with obesity (BMI between 30 and 49.9) who are scheduled for non-emergency surgeries requiring general anesthesia. Participants must be able to consent in English or Spanish, not have severe lung or heart disease, and not be pregnant or nursing.

Inclusion Criteria

I am scheduled for a planned surgery that will use general anesthesia.

My BMI is 30 or higher.

I can give my consent in English or Spanish.

Exclusion Criteria

Pregnant or nursing women

My BMI is either above 50 or below 30.

I have a high risk of aspiration due to conditions like gastroparesis or severe GERD.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Anesthesia

Participants undergo surgery with either a second-generation LMA or endotracheal tube, following a standardized anesthetic protocol

Intra-operative

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative hypoxia and other vital signs in the PACU

Up to 80 minutes post-operatively

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Endotracheal Intubation
• Second-Generation Laryngeal Mask Airway

Trial Overview The study compares the effectiveness of a second-generation Laryngeal Mask Airway (LMA) versus an Endotracheal Tube in obese patients during surgery. It's a randomized trial where participants will receive standard anesthetic care.

Participant Groups

Group I: Standard Endotracheal Tube Active Control 1 Intervention

Group II: Second-Generation LMA Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+