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Набор скоро начнётся NCT07303972

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

Без фазы С лечением Lung Perfusion Respiratory Physiology Electrical Impedance Tomography Ventilation-Perfusion Mismatch

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Electrical Impedance Tomography Saline Indicator Procedure, Electrical Impedance Tomography Device.
Кому может быть актуально
Состояния в реестре: Lung Perfusion, Respiratory Physiology, Electrical Impedance Tomography, Ventilation-Perfusion Mismatch. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура 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 reco
  • Устройство 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.

Первичные конечные точки

  • Global Lung Perfusion Distribution [Срок оценки: During the study procedure (within 1 hour)]
Вторичные конечные точки (1)
  • Global Lung Perfusion Heterogeneity Index [Срок оценки: During the study procedure (within 1 hour)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07303972 · EIT-BH-PERF-2025-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗