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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 80 minutes post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 80 minutes post-operatively
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 moreTrial Design
2Treatment groups
Active Control
Group I: Standard Endotracheal TubeActive Control1 Intervention
Group II: Second-Generation LMAActive Control1 Intervention
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,055 Previous Clinical Trials
1,054,569 Total Patients Enrolled
23 Trials studying Obesity
5,159 Patients Enrolled for Obesity
M.D. Anderson Cancer CenterOTHER
2,987 Previous Clinical Trials
1,797,714 Total Patients Enrolled
9 Trials studying Obesity
2,218 Patients Enrolled for Obesity
Tiffany S Moon, M.D.Principal InvestigatorUniversity of Texas
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is either above 50 or below 30.I have a high risk of aspiration due to conditions like gastroparesis or severe GERD.I am scheduled to stay in the ICU after my surgery.I am either younger than 18 or older than 80.My upcoming surgery is expected to last more than 4 hours.I am scheduled for a planned surgery that will use general anesthesia.I will undergo or have undergone laparoscopic surgery.I am between 18 and 80 years old.My BMI is 30 or higher.I have never had surgery on my stomach.My surgery was performed in a position other than lying flat on my back.I can give my consent in English or Spanish.I do not have severe lung or heart disease.I do not speak English or Spanish.I have chosen not to participate in this trial.I am planned to have anesthesia that doesn't put me fully to sleep.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Endotracheal Tube
- Group 2: Second-Generation LMA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT03748342 — N/A
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