EIT-Guided Visual Feedback During Incentive Spirometry for Postoperative Atelectasis
26 de junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Porcelana, 200032
- Zhongshan hospital, Fudan university
-
Contacto:
- Kai Liu, BSc
- Número de teléfono: +86-13512136346
- Correo electrónico: Liu.kai1@zs-hospital.sh.cn
-
Investigador principal:
- Kai Liu, BSc
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
|
Comparador activo: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Dorsal Ventilation Fraction
Periodo de tiempo: Baseline and 5 minutes after completion of the single intervention session
|
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.
|
Baseline and 5 minutes after completion of the single intervention session
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Inspiratory Volume
Periodo de tiempo: Day 1, during the single intervention session of 30 incentive-spirometry breaths
|
Mean volume or device scale reached across the 30 incentive-spirometry breaths performed during the training session.
|
Day 1, during the single intervention session of 30 incentive-spirometry breaths
|
|
Change in Global Inhomogeneity Index
Periodo de tiempo: Baseline and 5 minutes after completion of the single intervention session
|
The EIT-derived global inhomogeneity index at T1 minus the value at T0. Lower values indicate improved ventilation homogeneity.
|
Baseline and 5 minutes after completion of the single intervention session
|
|
Change in End-Expiratory Lung Impedance
Periodo de tiempo: Baseline and 5 minutes after completion of the single intervention session
|
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.
|
Baseline and 5 minutes after completion of the single intervention session
|
|
Change in Dependent Silent Spaces
Periodo de tiempo: Baseline and 5 minutes after completion of the single intervention session
|
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.
|
Baseline and 5 minutes after completion of the single intervention session
|
|
Change in Oxygen Saturation to Inspired Oxygen Ratio
Periodo de tiempo: Baseline and 5 minutes after completion of the single intervention session
|
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.
|
Baseline and 5 minutes after completion of the single intervention session
|
|
In-Hospital Intubation or Reintubation
Periodo de tiempo: From enrollment through hospital discharge, up to 30 days
|
Proportion of participants who undergo tracheal intubation or reintubation after study enrollment.
|
From enrollment through hospital discharge, up to 30 days
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Intervention-Related Adverse Events
Periodo de tiempo: From the start of the single intervention session through 24 hours after completion of the session
|
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.
|
From the start of the single intervention session through 24 hours after completion of the session
|
|
Change in PaO2/FiO2 Ratio
Periodo de tiempo: Baseline and 5 minutes after completion of the single intervention session, when routine arterial blood gas data are available
|
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.
|
Baseline and 5 minutes after completion of the single intervention session, when routine arterial blood gas data are available
|
|
ICU Length of Stay
Periodo de tiempo: From ICU admission through ICU discharge, up to 30 days
|
Number of calendar days from ICU admission to ICU discharge, descriptively summarized.
|
From ICU admission through ICU discharge, up to 30 days
|
|
Escalation of Respiratory Support
Periodo de tiempo: From enrollment through hospital discharge, up to 30 days
|
Number and proportion of participants requiring escalation of respiratory support after enrollment, including invasive ventilation or reintubation, noninvasive ventilation, or high-flow nasal oxygen.
|
From enrollment through hospital discharge, up to 30 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de junio de 2026
Publicado por primera vez (Actual)
2 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- KY2026002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .