EIT-Guided Visual Feedback During Incentive Spirometry for Postoperative Atelectasis
26 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200032
- Zhongshan hospital, Fudan university
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Contact:
- Kai Liu, BSc
- Numéro de téléphone: +86-13512136346
- E-mail: Liu.kai1@zs-hospital.sh.cn
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Chercheur principal:
- Kai Liu, BSc
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Dorsal Ventilation Fraction
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean Inspiratory Volume
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Intervention-Related Adverse Events
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
31 décembre 2027
Achèvement de l'étude (Estimé)
31 décembre 2027
Dates d'inscription aux études
Première soumission
9 juin 2026
Première soumission répondant aux critères de contrôle qualité
26 juin 2026
Première publication (Réel)
2 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- KY2026002
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
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Non
Étudie un produit d'appareil réglementé par la FDA américaine
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