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NCT Number: NCT07681232

EIT-Guided Visual Feedback During Incentive Spirometry for Postoperative Atelectasis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location contact

Kai Liu, BSc

CONTACT

[email protected]

+86-13512136346

Kai Liu, BSc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Dorsal Ventilation Fraction

    Time frame: 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.

Secondary outcomes

  1. Mean Inspiratory Volume

    Time frame: 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.

  2. Change in Global Inhomogeneity Index

    Time frame: 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.

  3. Change in End-Expiratory Lung Impedance

    Time frame: 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.

  4. Change in Dependent Silent Spaces

    Time frame: 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.

  5. Change in Oxygen Saturation to Inspired Oxygen Ratio

    Time frame: 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.

  6. In-Hospital Intubation or Reintubation

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

    Proportion of participants who undergo tracheal intubation or reintubation after study enrollment.

Other outcomes

  1. Intervention-Related Adverse Events

    Time frame: 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.

  2. Change in PaO2/FiO2 Ratio

    Time frame: 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.

  3. ICU Length of Stay

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

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

  4. Escalation of Respiratory Support

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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