EIT-Guided Respiratory Physiotherapy for Prolonged Mechanical Ventilation (PMV)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
EIT-Guided Respiratory Physiotherapy
Other interventionRespiratory 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
Conventional Respiratory Physiotherapy
Other interventionRespiratory 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
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: EIT-Guided Respiratory PhysiotherapyExperimental treatment 1 intervention
Group B: Conventional Respiratory PhysiotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Ventilator-Free Days at Day 28 (VFD-28)
Ventilator-free days at day 28 (VFD-28) is 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 after extubation or decannulation is considered treatment failure according to the predefined protocol.
Time frame
28 daysSecondary outcomes
1
Successful liberation from invasive mechanical ventilation by day 28
Successful liberation is defined as remaining free from invasive mechanical ventilation for at least 72 consecutive hours.
Time frame
28 days2
Diaphragm ultrasound parameters
Diaphragmatic excursion, thickness, and thickening fraction measured by bedside ultrasound.
Time frame
Up to 28 days3
EIT-derived ventilation distribution indices
Regional ventilation distribution indices derived from electrical impedance tomography, analyzed as exploratory mechanistic outcomes and not used for primary outcome adjudication.
Time frame
During intervention period (up to 28 days)4
ICU Mobility Scale (IMS) change from baseline
Change in ICU Mobility Scale score from baseline to the highest achieved level during ICU stay.
Time frame
Up to ICU discharge or day 28Sponsors and contacts
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Source ClinicalTrials.gov