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

NCT07303972 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-26

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Electrical 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.

DEVICE

Electrical 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 & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-01-01
Completion
2028-01-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07303972 on ClinicalTrials.gov