Impact of 3D-EIT-Guided Acapella Breathing Training on Lung Ventilation Distribution | NCT07733843

NCT07733843

Overview

NCT ID: NCT07733843
Lead Sponsor: Shanghai Zhongshan HospitalOTHER
Official Title: Impact of Visualized 3D-EIT-Guided Acapella Breathing Training on Lung Ventilation Distribution: A Prospective Single-Center Randomized Controlled Trial
Brief 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. 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Jul 31, 2026Estimated
Primary Completion Date: Aug 1, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Estimated
Primary Purpose: Basic Science
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Yuxian WangContact
wang.yuxian@zs-hospital.sh.cn+86 021 6404 1990

Similar Studies

Participant Group/Arms

3D-EIT Visual Biofeedback GroupExperimental

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.

Device: Acapella Oscillating Positive Expiratory Pressure Breathing Exercise

Device: Real-Time 3D Electrical Impedance Tomography Visual Biofeedback

Conventional Acapella Training GroupActive 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.

Device: Acapella Oscillating Positive Expiratory Pressure Breathing Exercise