97 Participants Needed

Second-Generation LMA for Obesity

Recruiting at 1 trial location
MO
TS
Overseen ByTiffany S Moon, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

TS

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.
See 1 more

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.
See 9 more

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
2Treatment groups
Active Control
Group I: Standard Endotracheal TubeActive Control1 Intervention
Group II: Second-Generation LMAActive Control1 Intervention

Find a Clinic Near You

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+
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