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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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06518239
Enrollment
30
Registered
2024-07-24
Start date
2024-11-18
Completion date
2026-03-30
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

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

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.

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.

Interventions

DEVICEPeep 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.

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Optimal PEEPFrom the time of consent to the end of surgery, assessed up to 24 hours.Optimal positive end-expiratory pressure (PEEP) measured using the electrical impedance tomography (EIT) belt during surgery.

Secondary

MeasureTime frameDescription
Difference between EIT and standard of care measured PEEPFrom the time of consent to the end of surgery, assessed up to 24 hours.Measured difference between optimal positive end-expiratory pressure from the study device and the standard of care anesthesia machines.
Delays in extubationFrom the day of surgery to discharge, up to 1 weekNumber of delays in extubating the patient due to breathing complications during surgery.
Incidence of extubation complicationsFrom the day of surgery to discharge, up to 1 weekNumber of reintubations needed and/or failed extubations after surgery.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTinashe Maduke, MD, MPH

University of Missouri-Columbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026