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Effects of Inspiratory vs Expiratory Breath-Hold on Lung Perfusion Measured by EIT Saline Indicator Method: A Self-Controlled Study

Electrical Impedance Tomography Saline Indicator Technique for Assessing Differences in Lung Perfusion Between Inspiratory and Expiratory Breath-Hold Phases: A Prospective Self-Controlled Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07303972
Enrollment
100
Registered
2025-12-26
Start date
2026-01-01
Completion date
2028-01-01
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrical Impedance Tomography, Lung Perfusion, Respiratory Physiology, Ventilation-Perfusion Mismatch

Keywords

Electrical Impedance Tomography, Lung Perfusion, Saline Indicator, Breath-Hold, Inspiratory / Expiratory Phases, Regional Perfusion, Ventilation-Perfusion Matching

Brief summary

This study aims to compare lung perfusion distribution between inspiratory breath-hold and expiratory breath-hold phases using the saline indicator method combined with electrical impedance tomography (EIT). A self-controlled crossover design will be used in which each participant undergoes both breath-hold conditions with standardized rapid intravenous saline injections. The primary objective is to evaluate changes in global and regional pulmonary perfusion under different lung volume states. The findings may improve understanding of perfusion redistribution with lung inflation and support optimized ventilatory strategies in clinical practice.

Detailed description

Electrical impedance tomography (EIT) with saline bolus injection is a noninvasive technique capable of generating real-time regional lung perfusion images based on transient impedance changes. Lung perfusion is highly dependent on lung volume, vascular resistance, and gravity, yet quantitative bedside evaluation remains limited. This prospective self-controlled study investigates the differences in lung perfusion between inspiratory breath-hold (near total lung capacity) and expiratory breath-hold (near functional residual capacity). Each participant will undergo two standardized procedures: (1) expiratory breath-hold followed by a rapid intravenous injection of saline, and (2) inspiratory breath-hold followed by the same injection protocol. The order will be randomized. Perfusion images will be reconstructed using time-impedance curves derived from saline indicator dilution. Regional perfusion parameters, including dependent vs nondependent zones and global perfusion distribution, will be compared between the two phases. This study may provide foundational physiological evidence for understanding perfusion redistribution across lung volumes and support the clinical application of EIT in respiratory monitoring, ventilatory management, and rehabilitation in critically ill patients.

Interventions

PROCEDUREElectrical Impedance Tomography Saline Indicator Procedure

Participants undergo continuous electrical impedance tomography (EIT) monitoring with a circumferential electrode belt placed around the thorax. During the procedure, participants perform standardized inspiratory and expiratory breath-hold maneuvers. At each breath-hold phase, a rapid intravenous bolus of sterile saline (10-20 mL) is administered, followed by a saline flush, to generate transient impedance changes for lung perfusion imaging using the saline indicator technique. EIT data are recorded continuously before, during, and after each saline injection. Each participant undergoes both breath-hold conditions and serves as their own control.

DEVICEElectrical Impedance Tomography Device

An FDA-cleared electrical impedance tomography (EIT) device is used to noninvasively monitor thoracic impedance changes during the study procedures. The device is used solely for physiological monitoring and image acquisition and is not being evaluated for safety, performance, or a new indication.

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18 to 65 years * Able to provide written informed consent * Able to perform standardized inspiratory and expiratory breath-hold maneuvers for at least 8 seconds * No known acute cardiopulmonary disease * Suitable for noninvasive electrical impedance tomography monitoring and intravenous saline administration

Exclusion criteria

* Known severe cardiopulmonary disease (e.g., advanced chronic obstructive pulmonary disease, severe pulmonary hypertension, or heart failure) * Hemodynamic instability or clinically significant cardiac arrhythmia * Contraindication to intravenous saline administration or fluid bolus * Pregnancy or breastfeeding * Skin conditions or chest wall abnormalities preventing proper placement of EIT electrodes

Design outcomes

Primary

MeasureTime frameDescription
Global Lung Perfusion DistributionDuring the study procedure (within 1 hour)Quantitative assessment of global lung perfusion distribution derived from saline-induced impedance changes measured by electrical impedance tomography during inspiratory and expiratory breath-hold phases. Global perfusion is expressed as the percentage contribution of regional perfusion relative to total lung perfusion.

Secondary

MeasureTime frameDescription
Global Lung Perfusion Heterogeneity IndexDuring the study procedure (within 1 hour)Spatial heterogeneity of lung perfusion quantified using a perfusion heterogeneity index derived from regional perfusion maps obtained with the electrical impedance tomography saline indicator technique.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026