Impact of Visualized 3D-EIT-Guided Acapella Breathing Training on Lung Ventilation Distribution: A Prospective Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Change From Baseline in End-Expiratory Lung Impedance (ΔEELI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change From Baseline in End-Expiratory Lung Impedance (ΔEELI)
时间窗: From baseline before the intervention to 10 minutes after completion of the single Acapella training session
Change in end-expiratory lung impedance (ΔEELI) will be measured using three-dimensional electrical impedance tomography (3D-EIT). ΔEELI is defined as the EELI measured during the stable breathing period after the intervention minus the EELI measured during the stable breathing period before the intervention.
次要结局
- Change From Baseline in Dorsal Lung Ventilation Proportion(Baseline and after a 10-minute recovery period following the single Acapella training session)
- Change From Baseline in Global Inhomogeneity Index(Baseline and after a 10-minute recovery period following the single Acapella training session)