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Second-Generation LMA for Obesity

N/A
Waitlist Available
Led By Tiffany S Moon, M.D.
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for a non-emergent surgery that requires general anesthesia (e.g., orthopedic, breast, urological, colorectal, ENT, vascular, general surgery)
18-80 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intra-operatively
Awards & highlights

Study Summary

This trial will compare the efficacy of a second-generation LMA to endotracheal intubation in 148 patients with a BMI of 30-49.9 kg/m2.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed, typical risks may include sore throat, difficulty swallowing, hoarseness, and less commonly aspiration or airway injury related to the use of LMA or endotracheal tubes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a planned surgery that will use general anesthesia.
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I am between 18 and 80 years old.
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My BMI is 30 or higher.
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I do not have severe lung or heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 80 minutes post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 80 minutes post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative hypoxia
Secondary outcome measures
Alterations in blood pressure
Alterations in heart rate
Alterations in oxygen saturation
+1 more

Trial Design

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

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,499 Total Patients Enrolled
23 Trials studying Obesity
5,159 Patients Enrolled for Obesity
M.D. Anderson Cancer CenterOTHER
2,967 Previous Clinical Trials
1,804,502 Total Patients Enrolled
9 Trials studying Obesity
2,218 Patients Enrolled for Obesity
Tiffany S Moon, M.D.Principal InvestigatorUniversity of Texas

Media Library

Endotracheal Intubation Clinical Trial Eligibility Overview. Trial Name: NCT03748342 — N/A
Obesity Research Study Groups: Standard Endotracheal Tube, Second-Generation LMA
Obesity Clinical Trial 2023: Endotracheal Intubation Highlights & Side Effects. Trial Name: NCT03748342 — N/A
Endotracheal Intubation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03748342 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT03748342 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I able to be enrolled in this clinical experiment?

"In order to join this research program, volunteers must be obese and fall between 18-80 years of age. A total of 300 individuals are being sought for the trial."

Answered by AI

Does this research endeavor exclude individuals aged 35 and above?

"Eligibility criteria for this trial requires that participants are aged 18 years or older, but not yet reached the age of 80."

Answered by AI

How many people are participating in the experiment at its peak?

"Indeed, the particulars of this clinical trial are available on clinicaltrials.gov; it is actively recruiting at present and was initially posted on June 27th 2019. The most recent update occurred in February 2022 and 300 patients will be accepted from one medical site."

Answered by AI

Are researchers still seeking subjects for this experiment?

"Affirmative. According to clinicaltrials.gov, this study commenced on June 27th 2019 and was recently updated on February 11th 2022; presently they are looking for 300 participants at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Parkland Health & Hospital System
MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tired so many things over the counter and working out, walking to lose weight and its on a stand still for years. I hate being fat.
PatientReceived 1 prior treatment
~52 spots leftby Apr 2025