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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200032
- Zhongshan hospital, Fudan university
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コンタクト：
- Kai Liu, BSc
- 電話番号：+86-13512136346
- メール：Liu.kai1@zs-hospital.sh.cn
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主任研究者：
- Kai Liu, BSc
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Dorsal Ventilation Fraction
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Inspiratory Volume
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intervention-Related Adverse Events
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年6月9日
QC基準を満たした最初の提出物
2026年6月26日
最初の投稿 (実際)
2026年7月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月2日
QC基準を満たした最後の更新が送信されました
2026年6月26日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- KY2026002
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