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Completed

NCT Number: NCT06518239

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

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: EIT belt, electrical impedance tomography

Primary outcomes

  1. Optimal PEEP

    Time frame: From 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 outcomes

  1. Difference between EIT and standard of care measured PEEP

    Time frame: From 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.

  2. Delays in extubation

    Time frame: From the day of surgery to discharge, up to 1 week

    Number of delays in extubating the patient due to breathing complications during surgery.

  3. Incidence of extubation complications

    Time frame: From the day of surgery to discharge, up to 1 week

    Number of reintubations needed and/or failed extubations after surgery.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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