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EIT-Guided Visual Feedback During Incentive Spirometry for Postoperative Atelectasis

26 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200032
        • Zhongshan hospital, Fudan university
        • Contatto:
        • Investigatore principale:
          • Kai Liu, BSc

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Age 18 years or older.
  2. 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.
  3. Alert and able to understand and follow incentive-spirometry and EIT instructions.
  4. Bedside lung ultrasound shows atelectasis or markedly reduced aeration in dorsal or posterolateral lung regions, with the lung-ultrasound assessment recorded.
  5. Baseline EIT during quiet breathing in a semi-recumbent position shows insufficient dorsal ventilation with potential for improvement; dorsal ventilation fraction below 50%.
  6. 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:

  1. Ongoing invasive mechanical ventilation or noninvasive ventilation, or high-flow nasal oxygen when study conditions cannot be maintained stably.
  2. Hemodynamic instability or inability to tolerate a semi-recumbent position.
  3. Inability to cooperate with training or impaired consciousness.
  4. 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.
  5. Severe underlying pulmonary disease likely to substantially affect ventilation distribution and obscure the intervention effect.
  6. Chest-wall deformity or severe scoliosis affecting EIT image quality.
  7. Body mass index greater than 35 kg/m2.
  8. Pregnancy or breastfeeding.
  9. Current participation in another interventional clinical trial that could interfere with study outcomes.
  10. Any other condition that, in the investigator's judgment, makes participation inappropriate.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: EIT-Guided Incentive Spirometry
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.
Comparatore attivo: 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.
Comportamentale: Standardized Incentive Spirometry Guidance
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Dorsal Ventilation Fraction
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Inspiratory Volume
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Intervention-Related Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai Zhongshan Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

9 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • KY2026002

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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