EIT-Guided Visual Feedback During Incentive Spirometry for Postoperative Atelectasis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EIT-Guided Incentive Spirometry

    Behavioral

    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.

  • Standardized Incentive Spirometry Guidance

    Behavioral

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: EIT-Guided Visual FeedbackExperimental treatment 1 intervention
Group B: Standardized Verbal GuidanceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Dorsal Ventilation Fraction

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.

Time frame
Baseline and 5 minutes after completion of the single intervention session

Secondary outcomes

1

Mean Inspiratory Volume

Mean volume or device scale reached across the 30 incentive-spirometry breaths performed during the training session.

Time frame
Day 1, during the single intervention session of 30 incentive-spirometry breaths
2

Change in Global Inhomogeneity Index

The EIT-derived global inhomogeneity index at T1 minus the value at T0. Lower values indicate improved ventilation homogeneity.

Time frame
Baseline and 5 minutes after completion of the single intervention session
3

Change in End-Expiratory Lung Impedance

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.

Time frame
Baseline and 5 minutes after completion of the single intervention session
4

Change in Dependent Silent Spaces

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.

Time frame
Baseline and 5 minutes after completion of the single intervention session

Other outcomes

1

Intervention-Related Adverse Events

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.

Time frame
From the start of the single intervention session through 24 hours after completion of the session
2

Change in PaO2/FiO2 Ratio

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.

Time frame
Baseline and 5 minutes after completion of the single intervention session, when routine arterial blood gas data are available
3

ICU Length of Stay

Number of calendar days from ICU admission to ICU discharge, descriptively summarized.

Time frame
From ICU admission through ICU discharge, up to 30 days
4

Escalation of Respiratory Support

Number and proportion of participants requiring escalation of respiratory support after enrollment, including invasive ventilation or reintubation, noninvasive ventilation, or high-flow nasal oxygen.

Time frame
From enrollment through hospital discharge, up to 30 days

Sponsors and contacts

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