Peep Belt for Obesity

Overseen By Paige Spencer, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tinashe Maduke

Disqualifiers: Pregnancy, Pacemaker, Neurostimulator, others

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

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

Do I need to stop my current medications for the Peep Belt trial?

The trial information does not specify whether you need to stop taking your current medications.

How does the Peep Belt treatment for obesity differ from other treatments?

The Peep Belt treatment for obesity is unique because it likely offers a non-invasive, wearable option compared to more invasive procedures like bariatric surgery or the use of intragastric balloons, which require medical intervention. This could make it a more accessible and less risky alternative for individuals seeking weight loss solutions. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to determine whether the Enlight 2100 electrical impedance tomography (EIT) belt can optimize positive end-expiratory pressure (PEEP) during surgery better than standard anesthesia machines.

Research Team

Tinashe Maduke, MD, MPH

Principal Investigator

University of Missouri-Columbia

Eligibility Criteria

This trial is for adults with a BMI of 40 kg/m2 or higher, who are scheduled for elective laparoscopic abdominal surgery in the steep Trendelenburg position and can provide informed consent. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

I can understand and agree to the study's procedures and risks.

My BMI is 40 or higher.

I am older than 18 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intraoperative Monitoring

The Enlight 2100 EIT belt is used to measure and optimize PEEP settings during surgery

Up to 24 hours

Postoperative Follow-up

Participants are monitored for extubation complications and other outcomes from surgery to discharge

Up to 1 week

Treatment Details

Interventions

• Peep Belt

Trial Overview The study is testing if the Enlight 2100 EIT belt can better optimize PEEP during surgery compared to standard methods used by anesthesia machines. The goal is to see which method provides better outcomes for obese patients.

Participant Groups

Group I: PEEP Belt Experimental Treatment 1 Intervention

PEEP belt will be placed on the patient intraoperatively. All patients will be monitored using anesthesia machines as standard of care.

Who Is Running the Clinical Trial?

Tinashe Maduke

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

Minor weight loss of 5-10% can significantly reduce health risks associated with obesity, but very low-calorie diets alone are not effective for long-term weight management.

Bariatric surgery is a safe and effective option for morbidly obese patients, especially those with additional cardiovascular risk factors, with adjustable gastric banding being a viable alternative to other surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Overweight. III. Therapeutic strategies for weight reduction]. Pijl, H., Meinders, AE.[2006]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Minimally invasive treatment of obesity with the intragastric balloon: a review]. [2014]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Overweight. III. Therapeutic strategies for weight reduction]. [2006]

3. Germany pubmed.ncbi.nlm.nih.gov

Losing weight to achieve joint or hernia surgery: is the intragastric balloon the answer? [2023]

4. United States pubmed.ncbi.nlm.nih.gov

BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

The Swallowable Intragastric Balloon Combined with Lifestyle Coaching: Short-Term Results of a Safe and Effective Weight Loss Treatment for People Living with Overweight and Obesity. [2023]