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Not yet recruiting NCT07733843

Impact of 3D-EIT-Guided Acapella Breathing Training on Lung Ventilation Distribution

No phase Interventional Critical Illness Recovery Pulmonary Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acapella Oscillating Positive Expiratory Pressure Breathing Exercise, Real-Time 3D Electrical Impedance Tomography Visual Biofeedback.
Who it may be relevant to
Registry conditions: Critical Illness Recovery, Pulmonary Rehabilitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Visualized 3D-EIT-Guided Acapella Breathing Training on Lung Ventilation Distribution: A Prospective Single-Center Randomized Controlled Trial

Overview

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.

Interventions

  • Device Acapella Oscillating Positive Expiratory Pressure Breathing Exercise
    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.
  • Device Real-Time 3D Electrical Impedance Tomography Visual Biofeedback
    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.

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07733843 · B2026-441

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗