Critical Illness RecoveryNCT07733843
Impact of 3D-EIT-Guided Acapella Breathing Training on Lung Ventilation Distribution
A study testing Acapella Oscillating Positive Expiratory Pressure Breathing Exercise and Real-Time 3D Electrical Impedance Tomography Visual Biofeedback in people with Critical Illness Recovery and Pulmonary Rehabilitation, run by Shanghai Zhongshan Hospital.
Trial summary
The goal of this randomized clinical trial is to determine whether real-time visual feedback from three-dimensional electrical impedance tomography (3D-EIT) can improve the effects of Acapella breathing exercises in adults recovering from critical illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness Recovery, Pulmonary Rehabilitation
- What is being tested?
- Acapella Oscillating Positive Expiratory Pressure Breathing Exercise and Real-Time 3D Electrical Impedance Tomography Visual Biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2026to 21 Mar 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.
- Adult patients in the stable recovery phase following critical illness, breathing spontaneously, alert, and able to follow instructions (suggested Richmond Agitation-Sedation Scale [RASS] score of -1 to +1).
- Hemodynamically stable, with no vasopressor support or only a low and stable dose of vasopressors.
- Receiving stable low-flow oxygen therapy or equivalent non-escalating respiratory support, without an anticipated need for escalation in the short term.
- Clinically considered suitable for standardized Acapella breathing exercises.
- Able and willing to provide written informed consent.
Who cannot join
- Significant hemodynamic instability or clinically significant cardiac arrhythmia.
- Untreated pneumothorax or active hemoptysis.
- Severe chest wall skin injury or allergy to electrode materials that prevents application of the electrical impedance tomography electrodes.
- Significant delirium or inability to understand or follow study instructions.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Visualized 3D-EIT-Guided Acapella Breathing Training on Lung Ventilation Distribution: A Prospective Single-Center Randomized Controlled Trial
The goal of this randomized clinical trial is to determine whether real-time visual feedback from three-dimensional electrical impedance tomography (3D-EIT) can improve the effects of Acapella breathing exercises in adults recovering from critical illness. 3D-EIT is a noninvasive bedside imaging method that provides real-time information about how ventilation is distributed within the lungs.
Participants will be randomly assigned to one of two groups. Both groups will perform a standardized Acapella breathing exercise while 3D-EIT data and vital signs are recorded. Participants in the control group will receive routine verbal and demonstration-based breathing instructions without viewing the EIT images. Participants in the intervention group will receive the same instructions and will also view their own real-time 3D-EIT ventilation images. They will use this visual feedback to adjust their breathing with the goal of increasing ventilation in the dorsal regions of the lungs and/or achieving a more even distribution of ventilation.
Read more
The main question is whether 3D-EIT-guided visual feedback results in a greater improvement in end-expiratory lung impedance (EELI) after breathing exercise compared with routine instruction alone. The study will also examine changes in regional ventilation distribution, ventilation inhomogeneity, vital signs, breathing discomfort, comfort and tolerance, achievement of the breathing-training target, and adverse events.
Approximately 30 participants will be enrolled and randomly assigned in a 1:1 ratio to the two study groups.
- Being tested
- Acapella Oscillating Positive Expiratory Pressure Breathing Exercise, Real-Time 3D Electrical Impedance Tomography Visual Biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acapella Oscillating Positive Expiratory Pressure Breathing ExerciseDevice
Participants will perform standardized breathing exercises using an Acapella oscillating positive expiratory pressure device. Each session will consist of 3 sets of 8-10 breaths, with 10-15 seconds of rest between breaths and 1-2 minutes of rest between sets. Participants will be instructed to inhale slowly and exhale through the Acapella device. The resistance setting will be predetermined and kept unchanged throughout the session.
Real-Time 3D Electrical Impedance Tomography Visual BiofeedbackDevice
Participants in the experimental group will view their own real-time 3D electrical impedance tomography (3D-EIT) ventilation images while performing standardized Acapella breathing exercises. The visual feedback will be used to guide breathing adjustments with the aim of increasing dorsal lung ventilation and/or improving ventilation homogeneity. The 3D-EIT system will also record ventilation data for outcome assessment.
| Study group | Role | What they receive |
|---|---|---|
| 3D-EIT Visual Biofeedback Group | Experimental | Participants will perform standardized Acapella breathing exercises with real-time 3D-EIT visual biofeedback in addition to routine verbal and demonstration-based instructions. Participants will view their own ventilation images and adjust their breathing to increase dorsal ventilation and/or improve ventilation homogeneity. Receives: Device: Acapella Oscillating Positive Expiratory Pressure Breathing Exercise; Device: Real-Time 3D Electrical Impedance Tomography Visual Biofeedback |
| Conventional Acapella Training Group | Active comparator | Participants will perform standardized Acapella breathing exercises under routine verbal and demonstration-based instructions without access to real-time 3D-EIT visual feedback. 3D-EIT data will still be recorded for outcome assessment. Receives: Device: Acapella Oscillating Positive Expiratory Pressure Breathing Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in End-Expiratory Lung Impedance (ΔEELI)
Change in end-expiratory lung impedance (ΔEELI) will be measured using three-dimensional electrical impedance tomography (3D-EIT). ΔEELI is defined as the EELI measured during the stable breathing period after the intervention minus the EELI measured during the stable breathing period before the intervention.
Measured: From baseline before the intervention to 10 minutes after completion of the single Acapella training session
Secondary outcomes (2)
Change From Baseline in Dorsal Lung Ventilation Proportion
The proportion of ventilation distributed to the dorsal lung regions will be measured using 3D electrical impedance tomography (3D-EIT). Change will be calculated as the post-intervention value minus the baseline value.
Measured: Baseline and after a 10-minute recovery period following the single Acapella training session
Change From Baseline in Global Inhomogeneity Index
Ventilation inhomogeneity will be assessed using the Global Inhomogeneity (GI) Index derived from 3D-EIT data. Change will be calculated as the post-intervention GI Index minus the baseline GI Index.
Measured: Baseline and after a 10-minute recovery period following the single Acapella training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion21 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Illness RecoveryStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 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
- NCT07733843
- Sponsor's protocol ID
- B2026-441
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Visualized 3D-EIT-Guided Acapella Breathing Training on Lung Ventilation Distribution: A Prospective Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07733843
- Acronym / sponsor ID
- B2026-441
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 21 Mar 2027 (estimated)
- First posted
- 29 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.
The goal of this randomized clinical trial is to determine whether real-time visual feedback from three-dimensional electrical impedance tomography (3D-EIT) can improve the effects of Acapella breathing exercises in adults recovering from critical illness. 3D-EIT is a noninvasive bedside imaging method that provides real-time information about how ventilation is distributed within the lungs.
Participants will be randomly assigned to one of two groups. Both groups will perform a standardized Acapella breathing exercise while 3D-EIT data and vital signs are recorded. Participants in the control group will receive routine verbal and demonstration-based breathing instructions without viewing the EIT images. Participants in the intervention group will receive the same instructions and will also view their own real-time 3D-EIT ventilation images. They will use this visual feedback to adjust their breathing with the goal of increasing ventilation in the dorsal regions of the lungs and/or achieving a more even distribution of ventilation.
The main question is whether 3D-EIT-guided visual feedback results in a greater improvement in end-expiratory lung impedance (EELI) after breathing exercise compared with routine instruction alone. The study will also examine changes in regional ventilation distribution, ventilation inhomogeneity, vital signs, breathing discomfort, comfort and tolerance, achievement of the breathing-training target, and adverse events.
Approximately 30 participants will be enrolled and randomly assigned in a 1:1 ratio to the two study groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-EIT Visual Biofeedback Group | Experimental | Device: Acapella Oscillating Positive Expiratory Pressure Breathing Exercise, Device: Real-Time 3D Electrical Impedance Tomography Visual BiofeedbackParticipants will perform standardized Acapella breathing exercises with real-time 3D-EIT visual biofeedback in addition to routine verbal and demonstration-based instructions. Participants will view their own ventilation images and adjust their breathing to increase dorsal ventilation and/or improve ventilation homogeneity. |
| Conventional Acapella Training Group | Active comparator | Device: Acapella Oscillating Positive Expiratory Pressure Breathing ExerciseParticipants will perform standardized Acapella breathing exercises under routine verbal and demonstration-based instructions without access to real-time 3D-EIT visual feedback. 3D-EIT data will still be recorded for outcome assessment. |
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.
- Adult patients in the stable recovery phase following critical illness, breathing spontaneously, alert, and able to follow instructions (suggested Richmond Agitation-Sedation Scale [RASS] score of -1 to +1).
- Hemodynamically stable, with no vasopressor support or only a low and stable dose of vasopressors.
- Receiving stable low-flow oxygen therapy or equivalent non-escalating respiratory support, without an anticipated need for escalation in the short term.
- Clinically considered suitable for standardized Acapella breathing exercises.
Key exclusion criteria (5 listed)
- Significant hemodynamic instability or clinically significant cardiac arrhythmia.
- Untreated pneumothorax or active hemoptysis.
- Severe chest wall skin injury or allergy to electrode materials that prevents application of the electrical impedance tomography electrodes.
- Significant delirium or inability to understand or follow study instructions.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
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 |
|---|---|---|
| Acapella Oscillating Positive Expiratory Pressure Breathing ExerciseParticipants will perform standardized breathing exercises using an Acapella oscillating positive expiratory pressure device. Each session will consist of 3 sets of 8-10 breaths, with 10-15 seconds of rest between breaths and 1-2 minutes of rest between sets. Participants will be instructed to inhale slowly and exhale through the Acapella device. The resistance setting will be predetermined and kept unchanged throughout the session. | Device | 3D-EIT Visual Biofeedback Group, Conventional Acapella Training Group |
| Real-Time 3D Electrical Impedance Tomography Visual BiofeedbackParticipants in the experimental group will view their own real-time 3D electrical impedance tomography (3D-EIT) ventilation images while performing standardized Acapella breathing exercises. The visual feedback will be used to guide breathing adjustments with the aim of increasing dorsal lung ventilation and/or improving ventilation homogeneity. The 3D-EIT system will also record ventilation data for outcome assessment. | Device | 3D-EIT Visual Biofeedback Group |
Primary outcome
Change From Baseline in End-Expiratory Lung Impedance (ΔEELI)
Time frame: From baseline before the intervention to 10 minutes after completion of the single Acapella training session
Change in end-expiratory lung impedance (ΔEELI) will be measured using three-dimensional electrical impedance tomography (3D-EIT). ΔEELI is defined as the EELI measured during the stable breathing period after the intervention minus the EELI measured during the stable breathing period before the intervention.
2 secondary outcomes
Change From Baseline in Dorsal Lung Ventilation Proportion
Time frame: Baseline and after a 10-minute recovery period following the single Acapella training session
Change From Baseline in Global Inhomogeneity Index
Time frame: Baseline and after a 10-minute recovery period following the single Acapella training session
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 29 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.
Questions about this trial
What is this clinical trial studying?
A study testing Acapella Oscillating Positive Expiratory Pressure Breathing Exercise and Real-Time 3D Electrical Impedance Tomography Visual Biofeedback in people with Critical Illness Recovery and Pulmonary Rehabilitation, run by Shanghai Zhongshan Hospital.
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 5 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yuxian Wang (+86 021 6404 1990, wang.yuxian@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in End-Expiratory Lung Impedance (ΔEELI) (time frame: From baseline before the intervention to 10 minutes after completion of the single Acapella training 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 29 Jul 2026.