- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07341113
Positional Effects on Lung Ventilation and Perfusion in Obesity
Effects of Body Position on Ventilation and Perfusion Distribution in Obese and Non-Obese Healthy Volunteers Assessed by Electrical Impedance Tomography
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This will be a observational, physiological study involving healthy volunteers divided into two groups: Obese group (BMI 30 - 40 kg/m²) and non-obese group (BMI 18.5 - 24.9 kg/m²). Each participant will serve as their own control across body positions. Baseline measurements will be obtained in upright sitting, followed by randomized order of supine, Trendelenburg (30°), prone, left lateral, and right lateral. Participants' demographic and anthropometric data, including height, weight, chest circumference, waist circumference, and hip circumference, will be recorded. Medical history, current medication use, smoking status, and cumulative smoking exposure (pack-years) will be documented.
Electrical Impedance Tomography (EIT) measurements will be performed using the Infivision ET1000 device. All study procedures will take place in a private room within the General Intensive Care Unit of Koç University Hospital, with privacy ensured throughout the protocol. After removal of upper body clothing, an appropriately sized EIT belt, selected according to chest circumference, will be positioned circumferentially around the thorax at the level of the axillae. A pulse oximetry probe will be applied, and continuous monitoring of heart rate and peripheral oxygen saturation will be maintained during all measurements.
Following a 5-minute stabilization period in the upright sitting position, baseline EIT measurements will be obtained. The following parameters will be recorded: percentage of ventral ventilation, percentage of dorsal ventilation, percentage of ventral perfusion, percentage of dorsal perfusion, Match Index (MI), Dead Space Index (DI), Shunt Index (SI), Global Inhomogeneity Index (GI), and Center of Ventilation (CoV). To minimize potential carry-over effects, the sequence of positions will be randomized individually for each participant. Randomization will be performed using computer-generated random sequences (randomizer.org), with predefined randomization sets created prior to study initiation.
Each position will be maintained for approximately 5 minutes. In each position, end-expiratory lung impedance difference (ΔEELI) will be measured using the upright sitting position as the reference. The total duration of the study protocol is expected to be approximately 30 minutes per participant. The study will be completed once all measurements have been obtained in all positions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye), 34010
- Koç University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
-BMI between 18-25 kg/m² or 30-40 kg/m²
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-obese group
Non-obese healthy individuals with BMI between 18.5 - 25 kg/m²
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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.
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Obese group
Obese healthy individuals with BMI between 30 - 40 kg/m²
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MI
Time Frame: Periprocedural
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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.
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Periprocedural
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VV %
Time Frame: Periprocedural
|
Percentage of ventral ventilation across body positions.
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Periprocedural
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DV %
Time Frame: Periprocedural
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Percentage of dorsal ventilation across body positions.
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Periprocedural
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VP %
Time Frame: Periprocedural
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Percentage of ventral perfusion across body positions.
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Periprocedural
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DP %
Time Frame: Periprocedural
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Percentage of dorsal perfusion across body positions.
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Periprocedural
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DI %
Time Frame: Periprocedural
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Dead space index (DI), proportion (in %) of lung units (pixels or ROIs) that are ventilated but not perfused across body positions
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Periprocedural
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SI %
Time Frame: Periprocedural
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Shunt index (SI), proportion (in %) of lung units (pixels or ROIs) that are perfused but not ventilated across body positions
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Periprocedural
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GI
Time Frame: Periprocedural
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Global Inhomogeneity Index (0-100) quantifies how evenly ventilation is distributed across the lung regions.
Higher values indicate more heterogeneous ventilation distribution across the lung cross-section.
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Periprocedural
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CoV
Time Frame: Periprocedural
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Center of ventilation (CoV) describes the center of mass of the ventilation distribution along the ventrodorsal axis (0-100, from ventral to dorsal).
CoV <40% means more ventral ventilation while >50-55% means more dorsal ventilation.
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Periprocedural
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ΔEELI
Time Frame: Periprocedural
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ΔEELI represents the change in end-expiratory lung impedance measured by EIT between each body position and the upright sitting reference position, reflecting relative changes in end-expiratory lung volume associated with positioning.
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Periprocedural
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Heart rate
Time Frame: Periprocedural
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Heart rate per minute measured by pulse oximetry
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Periprocedural
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Oxygen saturation
Time Frame: Periprocedural
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Oxygen saturation measured by pulse oximetry
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Periprocedural
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Evren Şentürk, MD, Koç University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025.510.IRB2.232
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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