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

N/AEnrolling By InvitationNCT06518239

Tinashe Maduke20 enrolled

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Peep BeltDEVICE

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital

Columbia, Missouri, United States

Outcomes

Primary Outcomes

Optimal PEEP

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

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

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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