EIT-Guided Visual Feedback During Incentive Spirometry for Postoperative Atelectasis
2026年6月26日 更新者：Shanghai Zhongshan Hospital
Effects of Electrical Impedance Tomography-Guided Visual Feedback During Incentive Spirometry on the Immediate Ventilation Distribution in Postoperative Patients With Atelectasis: A Prospective Randomized Controlled Trial
This single-center randomized controlled trial will evaluate whether real-time visual feedback from electrical impedance tomography (EIT) improves the immediate distribution of lung ventilation during incentive spirometry in adults with postoperative atelectasis.
Approximately 60 participants will be randomized 1:1 to receive either EIT-guided visual feedback or standardized verbal guidance during one session of 30 incentive-spirometry breaths.
The primary outcome is the change in dorsal ventilation fraction from before training to 5 minutes after training.
Secondary outcomes include inspiratory capacity, ventilation homogeneity, dependent silent spaces, end-expiratory lung impedance, oxygenation, in-hospital intubation or reintubation, and intervention-related adverse events.
研究概览
地位
尚未招聘
条件
详细说明
Eligible adults recovering from major thoracic or upper-abdominal surgery will be screened using bedside lung ultrasound and baseline EIT. Participants must be spontaneously breathing, clinically stable, able to follow instructions, and have a baseline dorsal ventilation fraction below 50%.
After a 2-minute baseline EIT recording in a 30- to 45-degree semi-recumbent position, participants will be randomized through a central randomization system using stratified variable blocks based on baseline dorsal ventilation fraction. Both groups will complete three sets of 10 incentive-spirometry breaths. In the experimental group, the EIT screen will be visible and trained staff will provide real-time, target-directed feedback intended to increase ventilation in dependent dorsal lung regions. In the control group, the EIT screen will be concealed and participants will receive standardized verbal instructions without imaging feedback.
After training, participants will rest for 5 minutes and undergo a second 2-minute EIT recording under stable oxygen-therapy conditions. EIT outcomes will be calculated offline by assessors blinded to group assignment. Respiratory-support outcomes will be recorded through hospital discharge. Intervention-related adverse events will be recorded from the start of the single intervention session through 24 hours after completion of the session.
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200032
- Zhongshan hospital, Fudan university
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接触：
- Kai Liu, BSc
- 电话号码：+86-13512136346
- 邮箱：Liu.kai1@zs-hospital.sh.cn
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首席研究员：
- Kai Liu, BSc
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age 18 years or older.
- Admitted to an intensive care unit or postoperative monitoring unit after major thoracic or upper-abdominal surgery; tracheal tube removed; spontaneously breathing; and clinically stable.
- Alert and able to understand and follow incentive-spirometry and EIT instructions.
- Bedside lung ultrasound shows atelectasis or markedly reduced aeration in dorsal or posterolateral lung regions, with the lung-ultrasound assessment recorded.
- Baseline EIT during quiet breathing in a semi-recumbent position shows insufficient dorsal ventilation with potential for improvement; dorsal ventilation fraction below 50%.
- Written informed consent provided by the participant or legally authorized representative according to the ethics-approved process, with participant re-consent when decision-making capacity returns.
Exclusion Criteria:
- Ongoing invasive mechanical ventilation or noninvasive ventilation, or high-flow nasal oxygen when study conditions cannot be maintained stably.
- Hemodynamic instability or inability to tolerate a semi-recumbent position.
- Inability to cooperate with training or impaired consciousness.
- Unsuitable for EIT monitoring, including an implanted pacemaker or defibrillator incompatible with the device, severe skin disease at the electrode-belt site, or known relevant allergy.
- Severe underlying pulmonary disease likely to substantially affect ventilation distribution and obscure the intervention effect.
- Chest-wall deformity or severe scoliosis affecting EIT image quality.
- Body mass index greater than 35 kg/m2.
- Pregnancy or breastfeeding.
- Current participation in another interventional clinical trial that could interfere with study outcomes.
- Any other condition that, in the investigator's judgment, makes participation inappropriate.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：EIT-Guided Visual Feedback
Participants complete one standardized session of incentive spirometry while viewing the real-time EIT screen.
Trained staff provide target-directed feedback to increase ventilation in dependent dorsal lung regions.
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Participants perform three sets of 10 incentive-spirometry breaths while viewing real-time electrical impedance tomography images.
Trained staff provide standardized, target-directed feedback to increase ventilation in dependent dorsal lung regions.
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有源比较器：Standardized Verbal Guidance
Participants complete the same standardized session of incentive spirometry with the EIT screen concealed.
Trained staff provide standardized verbal instructions without imaging feedback.
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Participants perform three sets of 10 incentive-spirometry breaths with the EIT screen concealed.
Trained staff provide standardized verbal instructions on posture, slow sustained inspiration, a 2- to 3-second breath hold, and rest between breaths, without imaging feedback.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Dorsal Ventilation Fraction
大体时间：Baseline and 5 minutes after completion of the single intervention session
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Dorsal ventilation fraction is the percentage of tidal ventilation occurring in the dorsal lung region during stable spontaneous breathing.
The outcome is calculated as DVF at T1 minus DVF at T0 using 2-minute EIT recordings and a fixed offline analysis algorithm.
Higher values indicate a greater shift of ventilation toward the dorsal region.
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Baseline and 5 minutes after completion of the single intervention session
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Inspiratory Volume
大体时间：Day 1, during the single intervention session of 30 incentive-spirometry breaths
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Mean volume or device scale reached across the 30 incentive-spirometry breaths performed during the training session.
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Day 1, during the single intervention session of 30 incentive-spirometry breaths
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Change in Global Inhomogeneity Index
大体时间：Baseline and 5 minutes after completion of the single intervention session
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The EIT-derived global inhomogeneity index at T1 minus the value at T0. Lower values indicate improved ventilation homogeneity.
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Baseline and 5 minutes after completion of the single intervention session
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Change in End-Expiratory Lung Impedance
大体时间：Baseline and 5 minutes after completion of the single intervention session
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End-expiratory lung impedance at T1 minus the value at T0, derived from EIT.
An increase generally indicates an increase in end-expiratory lung volume.
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Baseline and 5 minutes after completion of the single intervention session
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Change in Dependent Silent Spaces
大体时间：Baseline and 5 minutes after completion of the single intervention session
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Percentage of dependent silent spaces at T1 minus the percentage at T0, derived from EIT.
A decrease indicates fewer dependent lung regions with little or no ventilation.
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Baseline and 5 minutes after completion of the single intervention session
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Change in Oxygen Saturation to Inspired Oxygen Ratio
大体时间：Baseline and 5 minutes after completion of the single intervention session
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The SpO2/FiO2 ratio at T1 minus the ratio at T0. SpO2 is averaged over a stable 30- to 60-second interval and FiO2 is determined from the concurrent oxygen-delivery settings.
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Baseline and 5 minutes after completion of the single intervention session
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In-Hospital Intubation or Reintubation
大体时间：From enrollment through hospital discharge, up to 30 days
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Proportion of participants who undergo tracheal intubation or reintubation after study enrollment.
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From enrollment through hospital discharge, up to 30 days
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intervention-Related Adverse Events
大体时间：From the start of the single intervention session through 24 hours after completion of the session
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Number and proportion of participants with adverse events related to EIT monitoring or incentive-spirometry training, including skin irritation or pressure discomfort, worsened dyspnea, persistent oxygen desaturation, dizziness, hemodynamic instability, or increased incisional pain requiring the session to stop.
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From the start of the single intervention session through 24 hours after completion of the session
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Change in PaO2/FiO2 Ratio
大体时间：Baseline and 5 minutes after completion of the single intervention session, when routine arterial blood gas data are available
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Change in PaO2/FiO2 from T0 to T1 when an arterial blood gas result is available from routine clinical care.
No arterial blood sample is collected solely for this study.
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Baseline and 5 minutes after completion of the single intervention session, when routine arterial blood gas data are available
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ICU Length of Stay
大体时间：From ICU admission through ICU discharge, up to 30 days
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Number of calendar days from ICU admission to ICU discharge, descriptively summarized.
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From ICU admission through ICU discharge, up to 30 days
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Escalation of Respiratory Support
大体时间：From enrollment through hospital discharge, up to 30 days
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Number and proportion of participants requiring escalation of respiratory support after enrollment, including invasive ventilation or reintubation, noninvasive ventilation, or high-flow nasal oxygen.
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From enrollment through hospital discharge, up to 30 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年6月9日
首先提交符合 QC 标准的
2026年6月26日
首次发布 (实际的)
2026年7月2日
研究记录更新
最后更新发布 (实际的)
2026年7月2日
上次提交的符合 QC 标准的更新
2026年6月26日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- KY2026002
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.