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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special belt, called the PEEP Belt, to determine if it manages breathing during surgery more effectively than standard machines. It focuses on individuals with severe obesity (BMI of 40 or higher) undergoing specific types of abdominal surgery. Those with a BMI of 40 or more who are scheduled for such surgery might be suitable candidates. The trial aims to improve safe breathing support during surgery using this new belt. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance surgical safety for patients with severe obesity.

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.

What prior data suggests that the Peep Belt is safe for optimizing PEEP during surgery?

Research shows that using high positive end-expiratory pressure (PEEP) during surgery is safe for patients, including those who are obese. Studies have found that adjusting PEEP levels for each person is effective and generally well-tolerated. This approach tailors the treatment to individual needs, reducing potential risks.

The Peep Belt is a tool designed to optimize these PEEP levels during surgery. Although specific studies on the Peep Belt are not available, the general method of adjusting PEEP levels has been safely used in surgeries. This suggests that the Peep Belt, which aims to enhance this process, is likely safe as well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Peep Belt is unique because it introduces a novel approach to managing obesity by being placed on the patient intraoperatively. Unlike traditional methods such as lifestyle modifications, medications, or bariatric surgery, which can be invasive or require long-term adherence, the Peep Belt offers a potentially less invasive and more immediate intervention. Researchers are excited about this treatment because it integrates seamlessly with standard anesthesia equipment, potentially providing a new avenue for managing obesity during surgical procedures without additional burden on the patient.

What evidence suggests that the Peep Belt is effective for optimizing PEEP during surgery?

Research shows that using a Peep Belt during surgery might help people with obesity breathe better. Studies have found that higher levels of positive end-expiratory pressure (PEEP) can improve oxygen levels and breathing, especially for obese patients. One study discovered that obese individuals often need more PEEP to keep their lungs working well during surgery. Another review found that using PEEP along with techniques to open up the lungs is more effective for improving oxygen levels in obese patients. In this trial, researchers will place the Peep Belt on patients intraoperatively to assess its effectiveness in managing breathing during surgery for those with obesity. ^{4 6 7 8 9}

Who Is on the Research Team?

Tinashe Maduke, MD, MPH

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2735541

Effect of Intraoperative High Positive End-Expiratory ... This randomized trial compares the effects of higher levels of positive end-expiratory pressure (PEEP) with alveolar recruitment maneuvers ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01267916

Intrinsic PEEP During Mechanical Ventilation of Patients ... The investigators tried to research the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese ...

3. researchgate.net researchgate.net/publication/383195674_The_influence_of_BMI_on_optimal_PEEP_titrated_by_electrical_impedance_tomography_in_ARDS_patients

(PDF) The influence of BMI on optimal PEEP titrated by ... Compared to non-obese patients, the titrated PEEP was higher in obese patients (12 [12–15] cmH2O vs 9 [6–12] cmH2O, p < 0.001). At the PEEP ...

4. journals.lww.com journals.lww.com/joacp/fulltext/2025/01000/effects_of_intraoperative_recruitment_maneuver_in.5.aspx

Effects of intraoperative recruitment maneuver in patients... All studies in the review concluded that RM with PEEP was more effective in improving oxygenation and respiratory mechanics in patients with obesity undergoing ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0169260725004092

An EIT-based assessment of regional ventilation delay ... Overweight subjects exhibited no significant difference in Mean RVD between ZEEP and PEEP (p = 0.103). In contrast, non-overweight subjects demonstrated a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10662970/

The pressure for high PEEP in obese surgical patients is ... Using different approaches for identifying the optimal PEEP level, both studies found individualized PEEP levels to be >15 cmH2O in obese (Body Mass Index (BMI) ...

7. sciencedirect.com sciencedirect.com/org/science/article/pii/S1538958821001193

Article A Simulation Study on the Efficacy of Advanced Belt ... Objective: Recent field data analyses have shown that the safety advantages of rear seats relative to the front seats have decreased in newer vehicles.

8. researchgate.net researchgate.net/publication/229433899_Effects_of_Obesity_on_Seat_Belt_Fit

(PDF) Effects of Obesity on Seat Belt Fit Each 10 kg/m(2) increase in BMI was associated with an increase in lap belt webbing length of 130 mm. The worsening of lap belt fit with ...

9. apsf.org apsf.org/article/advanced-respiratory-monitoring-therapies-in-the-operating-room-a-new-frontier-for-obese-patients/

Advanced Respiratory Monitoring Therapies in the ... The incidence of postoperative pulmonary complications has been reported to exceed 20% in patients with class III obesity (BMI ≥ 40 kg/m2) undergoing major ...