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

Not Applicable

• Conditions: Obesity
• Interventions: Device: Peep Belt

• Registration Number: NCT06518239
• Lead Sponsor: Tinashe Maduke

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.

Study Timeline

• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-24
• Study Start: 2024-11-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-08
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Optimal PEEP	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 Outcome Measures

Name	Time	Method
Incidence of extubation complications	From the day of surgery to discharge, up to 1 week	Number of reintubations needed and/or failed extubations after surgery.
Difference between EIT and standard of care measured PEEP	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.
Delays in extubation	From the day of surgery to discharge, up to 1 week	Number of delays in extubating the patient due to breathing complications during surgery.

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Columbia, Missouri, United States