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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2026-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PEEP Belt

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

Group Type EXPERIMENTAL

Peep Belt

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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EIT belt electrical impedance tomography

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No