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

T

Tinashe Maduke

Status

Invitation-only

Conditions

Obesity

Treatments

Device: Peep Belt

Study type

Interventional

Funder types

Other

Identifiers

NCT06518239
2103228

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

PEEP Belt
Experimental group
Description:
PEEP belt will be placed on the patient intraoperatively. All patients will be monitored using anesthesia machines as standard of care.
Treatment:
Device: Peep Belt

Trial contacts and locations

1

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Central trial contact

Antoinette Burger, PhD; Paige Spencer, BS

Data sourced from clinicaltrials.gov

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