NCT07341113

Brief Summary

Electrical Impedance Tomography (EIT) is a non-invasive, bedside monitoring tool that provides real-time information on regional ventilation and perfusion. In particular, EIT has the potential to guide individualized mechanical ventilation in obese patients by revealing how gravitational and positional factors alter regional lung behavior. Assessing the effects of different horizontal positions on both ventilation and perfusion may help optimize respiratory management strategies tailored to body habitus. By comparing obese and non-obese healthy participants across different positions, this study aims to provide novel insights into the postural effects on lung aeration and perfusion distribution, and to highlight the role of EIT in tailoring individualized ventilation strategies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2026

Completed
Last Updated

April 15, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 15, 2025

Last Update Submit

April 13, 2026

Conditions

Keywords

obesityventilation perfusionelectrical impedance tomographybody positions

Outcome Measures

Primary Outcomes (1)

  • MI

    Match Index (MI, 0-100%): quantifying the spatial overlap of ventilation and perfusion distributions. MI values will be taken from the device's Match View. Change in Match Index (MI) between obese and non-obese participants across positions will be compared.

    Periprocedural

Secondary Outcomes (11)

  • VV %

    Periprocedural

  • DV %

    Periprocedural

  • VP %

    Periprocedural

  • DP %

    Periprocedural

  • DI %

    Periprocedural

  • +6 more secondary outcomes

Study Arms (2)

Non-obese group

Non-obese healthy individuals with BMI between 18.5 - 25 kg/m²

Other: Standardized body positioning

Obese group

Obese healthy individuals with BMI between 30 - 40 kg/m²

Other: Standardized body positioning

Interventions

Standardized changes in body position (supine, Trendelenburg, prone, and lateral positions) performed solely for physiologic assessment of ventilation and perfusion using electrical impedance tomography. This does not constitute a therapeutic or preventive intervention.

Non-obese groupObese group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy non-obese and obese volunteers

You may qualify if:

  • BMI between 18-25 kg/m² or 30-40 kg/m²

You may not qualify if:

  • Individuals with a body mass index (BMI) between 25 and 30 kg/m²,
  • Pregnancy
  • Respiratory tract infection within the previous two weeks
  • Anatomical abnormalities of the chest wall that may interfere with Electrical Impedance Tomography (EIT) measurements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koç University Hospital

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (1)

  • De Jong A, Wrigge H, Hedenstierna G, Gattinoni L, Chiumello D, Frat JP, Ball L, Schetz M, Pickkers P, Jaber S. How to ventilate obese patients in the ICU. Intensive Care Med. 2020 Dec;46(12):2423-2435. doi: 10.1007/s00134-020-06286-x. Epub 2020 Oct 23.

    PMID: 33095284BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Evren Şentürk, MD

    Koç University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2025

First Posted

January 14, 2026

Study Start

December 1, 2025

Primary Completion

March 5, 2026

Study Completion

March 5, 2026

Last Updated

April 15, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Data collected for the study, including de-identified individual participant data will be made available to other within 6 months after the publication of this trial, as will additional related documents (study protocol, statistical analysis plan and informed consent form), for academic purposes (e.g , meta-analyses) upon request to the corresponding author, and with a signed data access agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
6 months after the publication
Access Criteria
Academic purposes

Locations