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

Establishing Optimal PEEP Setting for Obese Patients in the Steep Trendelenburg Position: a Pilot Study.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity
• Intervention / Treatment: Device: Peep Belt

Detailed Description

Positive end-expiratory pressure (PEEP) is a measure taken intraoperatively to manage breathing during surgery. The Enlight 2100 is a device that uses electrical impedance tomography (EIT) to measure PEEP and provide a live image of the lungs while a patient is mechanically ventilated. In this study, the investigators will use the Enlight 2100 EIT belt to measure PEEP intraoperatively in order to better optimize PEEP settings for difficult cases.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEEP Belt; PEEP belt will be placed on the patient intraoperatively. All patients will be monitored using anesthesia machines as standard of care.	Device: Peep Belt; 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.; Other Names: EIT belt; electrical impedance tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between EIT and standard of care measured PEEP	Measured difference between optimal positive end-expiratory pressure from the study device and the standard of care anesthesia machines.	From the time of consent to the end of surgery, assessed up to 24 hours.
Delays in extubation	Number of delays in extubating the patient due to breathing complications during surgery.	From the day of surgery to discharge, up to 1 week
Incidence of extubation complications	Number of reintubations needed and/or failed extubations after surgery.	From the day of surgery to discharge, up to 1 week

Collaborators and Investigators

• Sponsor: Tinashe Maduke
• Investigators: Principal Investigator: Tinashe Maduke, MD, MPH, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: obesity; PEEP; positive end-expiratory pressure; electrical impedance tomography; EIT; steep trendelenburg; Trendelenburg
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: 2103228

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes