ObesityNCT06518239
Establishing Optimal PEEP Setting for Obese Patients in the Steep Trendelenburg Position
A study testing Peep Belt in people with Obesity, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Peep Belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 40 kg/m2
- Age > 18 years
- Scheduled for elective laparoscopic abdominal surgery in the steep Trendelenburg position.
- Able to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Optimal PEEP Setting for Obese Patients in the Steep Trendelenburg Position: a Pilot Study.
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Peep Belt
- Keywords
- obesity, steep trendelenburg, Trendelenburg, PEEP, positive end-expiratory pressure, EIT, electrical impedance tomography
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peep BeltDevice
Also called EIT belt, electrical impedance tomography
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.
| Study group | Role | What they receive |
|---|---|---|
| PEEP Belt | Experimental | PEEP belt will be placed on the patient intraoperatively. All patients will be monitored using anesthesia machines as standard of care. Receives: Device: Peep Belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal PEEP
Optimal positive end-expiratory pressure (PEEP) measured using the electrical impedance tomography (EIT) belt during surgery.
Measured: From the time of consent to the end of surgery, assessed up to 24 hours.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From the day of surgery to discharge, up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start18 Nov 2024
- Primary completion11 Feb 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoinette Burger, University of Missouri-Columbia
- Investigators
- Tinashe Maduke, MD, MPH, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518239
- Sponsor's protocol ID
- 2103228
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Optimal PEEP Setting for Obese Patients in the Steep Trendelenburg Position: a Pilot Study.
- ClinicalTrials.gov ID
- NCT06518239
- Acronym / sponsor ID
- 2103228
- Conditions
- Obesity
- Keywords
- obesity, steep trendelenburg, Trendelenburg, PEEP, positive end-expiratory pressure, EIT, electrical impedance tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PEEP Belt | Experimental | Device: Peep BeltPEEP belt will be placed on the patient intraoperatively. All patients will be monitored using anesthesia machines as standard of care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI ≥ 40 kg/m2
- Age > 18 years
- Scheduled for elective laparoscopic abdominal surgery in the steep Trendelenburg position.
- Able to provide informed consent.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peep BeltAlso: EIT belt, electrical impedance tomographyBelt 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. | Device | PEEP Belt |
Primary outcome
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.
3 secondary outcomes
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.
Delays in extubation
Time frame: From the day of surgery to discharge, up to 1 week
Incidence of extubation complications
Time frame: From the day of surgery to discharge, up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tinashe Maduke, MD, MPH principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peep Belt in people with Obesity, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal PEEP (time frame: From the time of consent to the end of surgery, assessed up to 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.