Impact of 3D-EIT-Guided Acapella Breathing Training on Lung Ventilation Distribution

Официальное название

Impact of Visualized 3D-EIT-Guided Acapella Breathing Training on Lung Ventilation Distribution: A Prospective Single-Center Randomized Controlled Trial

Обзор

The goal of this randomized clinical trial is to determine whether real-time visual feedback from three-dimensional electrical impedance tomography (3D-EIT) can improve the effects of Acapella breathing exercises in adults recovering from critical illness. 3D-EIT is a noninvasive bedside imaging method that provides real-time information about how ventilation is distributed within the lungs. Participants will be randomly assigned to one of two groups. Both groups will perform a standardized Acapella breathing exercise while 3D-EIT data and vital signs are recorded. Participants in the control group will receive routine verbal and demonstration-based breathing instructions without viewing the EIT images. Participants in the intervention group will receive the same instructions and will also view their own real-time 3D-EIT ventilation images. They will use this visual feedback to adjust their breathing with the goal of increasing ventilation in the dorsal regions of the lungs and/or achieving a more even distribution of ventilation. The main question is whether 3D-EIT-guided visual feedback results in a greater improvement in end-expiratory lung impedance (EELI) after breathing exercise compared with routine instruction alone. The study will also examine changes in regional ventilation distribution, ventilation inhomogeneity, vital signs, breathing discomfort, comfort and tolerance, achievement of the breathing-training target, and adverse events. Approximately 30 participants will be enrolled and randomly assigned in a 1:1 ratio to the two study groups.

Вмешательства

• Устройство Acapella Oscillating Positive Expiratory Pressure Breathing Exercise
  Participants will perform standardized breathing exercises using an Acapella oscillating positive expiratory pressure device. Each session will consist of 3 sets of 8-10 breaths, with 10-15 seconds of rest between breaths and 1-2 minutes of rest between sets. Participants will be instructed to inhale slowly and exhale through the Acapella device. The resistance setting will be predetermined and kept unchanged throughout the session.
• Устройство Real-Time 3D Electrical Impedance Tomography Visual Biofeedback
  Participants in the experimental group will view their own real-time 3D electrical impedance tomography (3D-EIT) ventilation images while performing standardized Acapella breathing exercises. The visual feedback will be used to guide breathing adjustments with the aim of increasing dorsal lung ventilation and/or improving ventilation homogeneity. The 3D-EIT system will also record ventilation data for outcome assessment.

Первичные конечные точки

• Change From Baseline in End-Expiratory Lung Impedance (ΔEELI) [Срок оценки: From baseline before the intervention to 10 minutes after completion of the single Acapella training session]

Вторичные конечные точки (2)

• Change From Baseline in Dorsal Lung Ventilation Proportion [Срок оценки: Baseline and after a 10-minute recovery period following the single Acapella training session]
• Change From Baseline in Global Inhomogeneity Index [Срок оценки: Baseline and after a 10-minute recovery period following the single Acapella training session]

Критерии участия

Критерии включения

• Age ≥18 years.
• Adult patients in the stable recovery phase following critical illness, breathing spontaneously, alert, and able to follow instructions (suggested Richmond Agitation-Sedation Scale \[RASS\] score of -1 to +1).
• Hemodynamically stable, with no vasopressor support or only a low and stable dose of vasopressors.
• Receiving stable low-flow oxygen therapy or equivalent non-escalating respiratory support, without an anticipated need for escalation in the short term.
• Clinically considered suitable for standardized Acapella breathing exercises.
• Able and willing to provide written informed consent.

Критерии исключения

• Significant hemodynamic instability or clinically significant cardiac arrhythmia.
• Untreated pneumothorax or active hemoptysis.
• Severe chest wall skin injury or allergy to electrode materials that prevents application of the electrical impedance tomography electrodes.
• Significant delirium or inability to understand or follow study instructions.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07733843 · B2026-441

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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