EIT-Guided Visual Feedback During Incentive Spirometry for Postoperative Atelectasis
26 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Não aplicável
Contactos e Locais
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Locais de estudo
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200032
- Zhongshan hospital, Fudan university
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Contato:
- Kai Liu, BSc
- Número de telefone: +86-13512136346
- E-mail: Liu.kai1@zs-hospital.sh.cn
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Investigador principal:
- Kai Liu, BSc
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Dorsal Ventilation Fraction
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Inspiratory Volume
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Intervention-Related Adverse Events
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
9 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de junho de 2026
Primeira postagem (Real)
2 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- KY2026002
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NÃO
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