Postoperative AtelectasisNCT07681232
EIT-Guided Visual Feedback During Incentive Spirometry for Postoperative Atelectasis
A study testing EIT-Guided Incentive Spirometry and Standardized Incentive Spirometry Guidance in people with Postoperative Atelectasis, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Atelectasis
- What is being tested?
- EIT-Guided Incentive Spirometry and Standardized Incentive Spirometry Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Kai Liu, BSc, +86-13512136346, Liu.kai1@zs-hospital.sh.cn
Kai Liu, BSc
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Postoperative Atelectasis
- Being tested
- EIT-Guided Incentive Spirometry, Standardized Incentive Spirometry Guidance
- Keywords
- Electrical Impedance Tomography, Incentive Spirometry, Visual Feedback, Pulmonary Rehabilitation, Dorsal Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIT-Guided Incentive SpirometryBehavioural
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 GuidanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EIT-Guided Visual Feedback | Experimental | 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. Receives: Behavioral: EIT-Guided Incentive Spirometry |
| Standardized Verbal Guidance | Active comparator | Participants complete the same standardized session of incentive spirometry with the EIT screen concealed. Trained staff provide standardized verbal instructions without imaging feedback. Receives: Behavioral: Standardized Incentive Spirometry Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 5 minutes after completion of the single intervention session
Secondary outcomes (6)
Mean Inspiratory Volume
Mean volume or device scale reached across the 30 incentive-spirometry breaths performed during the training session.
Measured: Day 1, during the single intervention session of 30 incentive-spirometry breaths
Change in Global Inhomogeneity Index
The EIT-derived global inhomogeneity index at T1 minus the value at T0. Lower values indicate improved ventilation homogeneity.
Measured: Baseline and 5 minutes after completion of the single intervention session
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.
Measured: Baseline and 5 minutes after completion of the single intervention session
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.
Measured: Baseline and 5 minutes after completion of the single intervention session
Change in Oxygen Saturation to Inspired Oxygen Ratio
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.
Measured: Baseline and 5 minutes after completion of the single intervention session
In-Hospital Intubation or Reintubation
Proportion of participants who undergo tracheal intubation or reintubation after study enrollment.
Measured: From enrollment through hospital discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to EIT-guided visual feedback or standardized verbal guidance during a single session of incentive spirometry.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681232
- Sponsor's protocol ID
- KY2026002
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07681232
- Acronym / sponsor ID
- KY2026002
- Conditions
- Postoperative Atelectasis
- Keywords
- Electrical Impedance Tomography, Incentive Spirometry, Visual Feedback, Pulmonary Rehabilitation, Dorsal Ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to EIT-guided visual feedback or standardized verbal guidance during a single session of incentive spirometry.
| Arm | Type | Receives |
|---|---|---|
| EIT-Guided Visual Feedback | Experimental | Behavioral: EIT-Guided Incentive SpirometryParticipants 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. |
| Standardized Verbal Guidance | Active comparator | Behavioral: Standardized Incentive Spirometry GuidanceParticipants complete the same standardized session of incentive spirometry with the EIT screen concealed. Trained staff provide standardized verbal instructions without imaging feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EIT-Guided Incentive SpirometryParticipants 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. | Behavioural | EIT-Guided Visual Feedback |
| Standardized Incentive Spirometry GuidanceParticipants 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. | Behavioural | Standardized Verbal Guidance |
Primary outcome
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.
6 secondary outcomes
Mean Inspiratory Volume
Time frame: Day 1, during the single intervention session of 30 incentive-spirometry breaths
Change in Global Inhomogeneity Index
Time frame: Baseline and 5 minutes after completion of the single intervention session
Change in End-Expiratory Lung Impedance
Time frame: Baseline and 5 minutes after completion of the single intervention session
Change in Dependent Silent Spaces
Time frame: Baseline and 5 minutes after completion of the single intervention session
Change in Oxygen Saturation to Inspired Oxygen Ratio
Time frame: Baseline and 5 minutes after completion of the single intervention session
In-Hospital Intubation or Reintubation
Time frame: From enrollment through hospital discharge, up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIT-Guided Incentive Spirometry and Standardized Incentive Spirometry Guidance in people with Postoperative Atelectasis, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dorsal Ventilation Fraction (time frame: Baseline and 5 minutes after completion of the single intervention session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.