EIT-Guided Respiratory Physiotherapy for Prolonged Mechanical Ventilation (PMV)
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: EIT-Guided Respiratory Physiotherapy, Conventional Respiratory Physiotherapy.
- Who it may be relevant to
- Registry conditions: Prolonged Mechanical Ventilation, Respiratory Failure, Critical Illness. 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
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Electrical Impedance Tomography-Guided Respiratory Physiotherapy for Liberation From Prolonged Mechanical Ventilation: A Multicenter Randomized Controlled Trial
Overview
Patients with prolonged mechanical ventilation (PMV) frequently experience impaired ventilation distribution, respiratory muscle dysfunction, secretion retention, and delayed liberation from mechanical ventilation. Electrical impedance tomography (EIT) provides real-time bedside visualization of regional ventilation and enables individualized respiratory physiotherapy strategies. This multicenter randomized controlled trial aims to evaluate whether EIT-guided respiratory physiotherapy improves ventilator-free days at day 28 compared with conventional respiratory physiotherapy in adult patients with PMV. Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. In the EIT-guided group, real-time EIT imaging is used to individualize physiotherapy strategies based on predefined ventilation distribution indicators, while the control group receives standardized physiotherapy according to institutional protocols without EIT guidance. Secondary outcomes include successful liberation from mechanical ventilation, diaphragm ultrasound parameters, EIT-derived ventilation distribution indices (exploratory mechanistic outcomes), ICU Mobility Scale, healthcare resource utilization, and safety outcomes.
Detailed description
This multicenter randomized controlled trial evaluates the effectiveness of electrical impedance tomography (EIT)-guided respiratory physiotherapy compared with conventional respiratory physiotherapy in adult patients with prolonged mechanical ventilation (PMV).
Eligible patients receiving invasive mechanical ventilation for at least 21 consecutive days will be randomly assigned in a 1:1 ratio to either the EIT-guided group or the control group, in addition to standard ICU care.
Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. Both groups will receive standardized physiotherapy protocols with comparable treatment frequency and duration.
In the EIT-guided group, real-time EIT imaging will be used during each physiotherapy session. The control group will receive the same standardized physiotherapy components according to institutional protocols without EIT guidance.
The primary outcome is ventilator-free days at day 28 (VFD-28), defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. Patients who die before day 28 or remain invasively ventilated at day 28 will be assigned a value of zero. Reintubation within 72 hours will be considered treatment failure according to the predefined protocol.
Secondary outcomes include successful liberation from invasive mechanical ventilation by day 28, diaphragm ultrasound parameters, EIT-derived ventilation distribution indices (exploratory mechanistic outcomes), ICU Mobility Scale (IMS), healthcare resource utilization, and safety outcomes.
EIT-derived parameters are included as exploratory mechanistic outcomes to characterize physiological responses to the intervention and are not used for primary outcome adjudication.
Interventions
- Other EIT-Guided Respiratory Physiotherapy
Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, individualized using real-time EIT guidance based on predefined ventilation distribution indicators. Link this intervention to: Experimental Arm - Other Conventional Respiratory Physiotherapy
Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, delivered according to standardized institutional protocols without EIT guidance. Link this intervention to: Control Arm
Primary outcome measures
- Ventilator-Free Days at Day 28 (VFD-28) [Time frame: 28 days]
Secondary outcome measures (8)
- Successful liberation from invasive mechanical ventilation by day 28 [Time frame: 28 days]
- Diaphragm ultrasound parameters [Time frame: Up to 28 days]
- EIT-derived ventilation distribution indices [Time frame: During intervention period (up to 28 days)]
- ICU Mobility Scale (IMS) change from baseline [Time frame: Up to ICU discharge or day 28]
- ICU length of stay [Time frame: Up to hospital discharge]
- Hospital length of stay [Time frame: From hospital admission to hospital discharge]
- Total hospitalization cost [Time frame: Up to hospital discharge]
- Adverse events during physiotherapy [Time frame: During intervention period (up to 28 days)]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years.
- Invasive mechanical ventilation for ≥ 21 consecutive days.
- Clinically stable and eligible for respiratory physiotherapy as determined by the treating team.
- Expected to remain on invasive mechanical ventilation for at least 48 hours after enrollment.
- Written informed consent obtained from the patient or legally authorized representative.
Exclusion criteria
- Contraindications to electrical impedance tomography .
- Hemodynamic instability requiring high-dose vasoactive support.
- Severe hypoxemia refractory to optimization.
- Unstable fractures or other contraindications to mobilization or positioning.
- Pregnancy.
- Expected death within 48 hours.
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
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Rehabilitation Hospital Affiliated to Capital Medical University — Beijing
Identifiers
NCT: NCT07372794 · 2026bkky0115ly