Establishing Optimal PEEP Setting for Obese Patients in the Steep Trendelenburg Position

NCT06518239 | Completed FDA Device

• 1 other identifier: 2103228
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

obesity; steep trendelenburg; Trendelenburg; PEEP; positive end-expiratory pressure; EIT; electrical impedance tomography

Outcome Measures

Primary Outcomes (1)

• Optimal PEEP

  Optimal positive end-expiratory pressure (PEEP) measured using the electrical impedance tomography (EIT) belt during surgery.

  From the time of consent to the end of surgery, assessed up to 24 hours.

Secondary Outcomes (3)

• Difference between EIT and standard of care measured PEEP

  From the time of consent to the end of surgery, assessed up to 24 hours.

• Delays in extubation

  From the day of surgery to discharge, up to 1 week

• Incidence of extubation complications

  From the day of surgery to discharge, up to 1 week

Study Arms (1)

PEEP Belt

EXPERIMENTAL

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

Device: Peep Belt

Interventions

Peep Belt DEVICE

Belt will be placed on the nipple line of the patient prior to the surgery start in the operating room. Data will be collected prior to the initial incision after the patient has been intubated, and then at the end of surgery before the patient has been extubated.

Also known as: EIT belt, electrical impedance tomography

PEEP Belt

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥ 40 kg/m2
• Age \> 18 years
• Scheduled for elective laparoscopic abdominal surgery in the steep Trendelenburg position.
• Able to provide informed consent.

You may not qualify if:

• Currently pregnant.
• Presence of pacemaker, neurostimulator, spinal cord stimulator, or implantable cardioverter-defibrillator.
• Skin ulcerations on upper torso near the belt placement.
• Presence of phrenic nerve palsy or other diaphragm conditions.
• Thoracic circumference \> 134 cm.
• Tracheomalacia.
• Inability to speak and understand English.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University Hospital

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tinashe Maduke, MD, MPH

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will be monitored by the standard of care anesthesia machines intraoperatively. An EIT belt will be attached to the patient intraoperatively, and data from the belt will be compared to the anesthesia machines.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 24, 2024
• Study Start: November 18, 2024
• Primary Completion: February 11, 2026
• Study Completion: March 30, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

US (1)