Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
NCT Number: NCT07681232
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200032, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: From enrollment through hospital discharge, up to 30 days
Proportion of participants who undergo tracheal intubation or reintubation after study enrollment.
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.
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.
Time frame: From ICU admission through ICU discharge, up to 30 days
Number of calendar days from ICU admission to ICU discharge, descriptively summarized.
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.
Shanghai Zhongshan Hospital
Other
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
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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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