Second-Generation LMA for Obesity

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods to assist breathing during surgery: a second-generation laryngeal mask airway (LMA) and the standard endotracheal tube. Researchers aim to determine which method is more effective and comfortable for patients who are obese and undergoing non-emergency surgeries. It is suitable for individuals with a BMI between 30 and 49.9 who are scheduled for surgeries such as orthopedic or urological procedures. Participants must not have severe lung or heart problems. As an unphased trial, this study allows participants to contribute to important research that could enhance surgical care for many.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the second-generation LMA is safe for patients with obesity?

Research has shown that second-generation Laryngeal Mask Airways (LMAs) are generally safe and effective for assisting patients' breathing during surgery. One study found that the LMA Protector™ provided a good seal and adequate ventilation in 99% of patients, indicating success in almost all cases.

Although these LMAs have been used in patients with obesity, further research is needed to confirm their safety for this group. They have been successfully used in various surgeries, including lengthy ones, suggesting they can reliably maintain open airways during operations.

Overall, second-generation LMAs appear well-tolerated with few reported issues, making them a promising option for surgeries. However, more studies are needed, particularly for patients with higher body weights. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Second-Generation Laryngeal Mask Airway (LMA) for obesity patients because it offers a less invasive alternative to endotracheal intubation. Unlike traditional intubation that requires passing a tube through the vocal cords, the Second-Generation LMA sits above the vocal cords, reducing the risk of airway trauma and post-operative sore throat. Additionally, this LMA is designed with a better seal and increased protection against aspiration, making it a safer and potentially more comfortable option for patients.

What evidence suggests that the second-generation LMA is effective for obesity surgery?

This trial will compare the use of a Second-Generation Laryngeal Mask Airway (LMA) with Standard Endotracheal Tube intubation for obese patients. Studies have shown that newer types of LMAs can assist obese patients in breathing during surgery. Specifically, one study found that the ProSeal™ LMA provided effective breathing support for patients with a BMI over 35 before full intubation. Another study with the LMA Protector™ demonstrated a good seal and sufficient ventilation in 99% of cases. These findings suggest that newer LMAs can reliably help obese patients breathe during surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Tiffany S Moon, M.D.

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03748342

Study Details | NCT03748342 | Second Generation LMA ... 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.

2. apsf.org apsf.org/article/the-laryngeal-mask-airway-expanding-use-beyond-routine-spontaneous-ventilation-for-surgery/

The Laryngeal Mask Airway: Expanding Use Beyond ... Keller et al. showed that the ProSeal™ LMA was temporarily effective in ventilating obese patients with a BMI >35 prior to intubation.28 Although second- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9441326/

results from the LMA® Protector™ observational study Overall, the LMA protector™ was able to maintain good seal and adequate ventilation in 110 patients 99 (95% CI 97.3–100)%; in one case the seal ...

4. journals.plos.org journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0321421&type=printable

Results of an international survey on the use and perceptions ... Our data shows considerable differences in the use of LMA among anaesthetists. ... laryngeal mask airway in moderately obese adults. Acta ...

5. journals.lww.com journals.lww.com/ijaweb/fulltext/2017/61050/comparison_of_actual_and_ideal_body_weight_for.6.aspx

Comparison of actual and ideal body weight for selection ... Obese patients are more inclined to have the smaller upper airways,[89] and it is more likely that a smaller mask will have a better sealing function due to the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12011215/

Results of an international survey on the use ... 121 anaesthetists (31.9%) reported considering an upper limit of Body-Mass-Index (BMI) when using a LMA (median 35 kg/m²), 186 (49.1%) reported ...

7. nature.com nature.com/articles/s41598-021-83173-5

Second generation laryngeal mask airway during ... The second-generation LMA can be considered as the effective airway devices for securing airway in patients undergoing prolonged laparoscopic surgery.